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Category: Psoriasis

Weekly Top News – Psoriasis – September 28, 2020

September 28, 2020

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma announces the launch of ILUMYA (tildrakizumab) for treatment of Plaque Psoriasis in Japan (Equitybulls) – Sep 23, 2020 – “Sun Pharmaceutical…today announced that its wholly-owned Japanese subsidiary has launched ILUMYA® Subcutaneous Injection 100 mg Syringe (Nonproprietary name: tildrakizumab (genetical recombination), ‘ILUMYA’) in Japan for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies.”

 

bimekizumab (UCB4940) / UCB
UCB Achieves Important Regulatory Milestone for Bimekizumab (UCB Press Release) – Sep 22, 2020 – “UCB…today announced that the FDA and EMA have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis; This accepted submission is supported by a robust data package including three Phase 3 studies which demonstrate superiority of bimekizumab to placebo, Stelara[®] (ustekinumab) and Humira[®] (adalimumab) in achieving skin clearance at week 16.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx: “Extension of indication to include the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy [Plaque psoriasis]” (European Medicines Agency) – Sep 25, 2020 – CHMP Final Minutes of the meeting on 22-25 June 2020: “The Committee adopted a positive opinion by consensus together with the CHMP assessment report and translation timetable”

 

Tremfya (guselkumab) / J&J
Tremfya: “Addition of a new indication for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy [Psoriatic arthritis]” (European Medicines Agency) – Sep 25, 2020 – CHMP Final Minutes of the meeting on 22-25 June 2020: “The Committee adopted a 2nd request for supplementary information with a specific timetable”

 

piclidenoson (CF101) / Can-Fite, China Medical System
Can-Fite to Participate in Two BioPharma Partnering Conferences (Businesswire) – Sep 22, 2020 – “Can-Fite BioPharma Ltd….today announced the Company’s VP of Business Development, Dr. Sari Fishman, is participating in two conferences where she will conduct one-on-one meetings with pharmaceutical companies for potential distribution and partnerships for the Company’s drug candidates, Piclidenoson and Namodenoson. Both conferences include scheduled virtual partner meetings for Can-Fite, live sessions, and virtual networking….Additional trials are ongoing or expected to start in COVID-19 and liver cancer.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasi (clinicaltrials.gov) – Sep 22, 2020 – P3; N=214; Active, not recruiting; Sponsor: Sun Pharma Global FZE; Recruiting –> Active, not recruiting; Trial completion date: Aug 2022 –> Feb 2022; Trial primary completion date: Jun 2021 –> Jan 2021

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Weekly Top News – Psoriasis – September 21, 2020

September 21, 2020

bimekizumab (UCB4940) / UCB
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO) (clinicaltrials.gov) – Sep 15, 2020 – P3; N=172; Completed; Sponsor: UCB Biopharma S.P.R.L.; Active, not recruiting –> Completed; N=38 –> 172

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
AbbVie brings together 300 dermatologists in a virtual meeting [Google translation] (Murcia.com) – Sep 17, 2020 – “The biopharmaceutical company AbbVie brings together 300 dermatologists in a virtual meeting to share scientific evidence and clinical development, on the occasion of the marketing in Spain of SKYRIZI® (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients candidates for systemic treatment….Throughout this meeting, the different studies that have shown efficacy rates significantly higher than other mechanisms of action of biological drugs already existing today will be shared, in the primary and secondary objectives analyzed, as well as a favorable safety profile will be shared.”

 

belumosudil (KD025 ) / Kadmon, Romeck Pharma
KD025: Patent expiry in 2035 (Kadmon, 22nd Annual H.C. Wainwright Global Investment Conference 2020 (Virtual Meeting)) – Sep 15, 2020
Patent
[Screenshot]

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Weekly Top News – Psoriasis – September 14, 2020

September 14, 2020

sonelokinab (M1095) / EMD Serono, Avillion
Avillion announces positive top-line results of Phase 2 trial of sonelokinab (M1095), an anti-IL-17 A/F Nanobody, in chronic psoriasis (PRNewswire) – Sep 10, 2020 – P2, N=313; NCT03384745; Sponsor: Bond Avillion 2 Development LP; “Avillion…announces the successful completion and positive top-line results of its Phase 2 trial of sonelokinab (M1095), an investigational anti-IL-17 A/F Nanobody, in patients with moderate to severe chronic plaque-type psoriasis. The study evaluated four dose regimens of sonelokinab, placebo and a reference arm of secukinumab….After completing enrolment of 313 patients, ahead of schedule, the trial met its primary endpoint based on Investigator’s Global Assessment (IGA) at week 12, and secondary endpoints (Psoriasis Area and Severity Index or PASI 75, PASI 90, and PASI 100 at week 12) with high statistical significance (p<0.001). Sonelokinab was also found to be generally well tolerated….Kim Papp…commented: ‘We have made significant advances in the treatment of psoriasis.'”

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Sep 8, 2020 – P3; N=108; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

Siliq (brodalumab) / Bausch Health, LEO Pharma, Kyowa Hakko Kirin
EMBRACE 1: Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis (clinicaltrials.gov) – Sep 11, 2020 – P3; N=120; Not yet recruiting; Sponsor: LEO Pharma; Trial completion date: Nov 2023 –> May 2024; Initiation date: Sep 2020 –> Apr 2021; Trial primary completion date: Jan 2023 –> Jun 2023

Siliq (brodalumab) / Bausch Health, LEO Pharma, Kyowa Hakko Kirin
Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight (clinicaltrials.gov) – Sep 11, 2020 – P4; N=384; Not yet recruiting; Sponsor: LEO Pharma; Trial completion date: Aug 2024 –> Nov 2025; Initiation date: Jun 2020 –> Apr 2021; Trial primary completion date: Apr 2024 –> Jun 2025
Clinical • Trial completion date • Trial initiation date • Trial primary completion date  

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Weekly Top News – Psoriasis – September 7, 2020

September 7, 2020

llllllllll Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
reSURFACE 1: A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010) (clinicaltrials.gov) – Aug 31, 2020 – P3; N=772; Completed; Sponsor: Sun Pharma Global FZE; Active, not recruiting –> Completed

 

llllllllll Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
reSURFACE 2: A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011) (clinicaltrials.gov) – Aug 31, 2020 – P3; N=1090; Completed; Sponsor: Sun Pharma Global FZE; Active, not recruiting –> Completed

 

llllllllll Siliq (brodalumab) / Bausch Health, LEO Pharma, Kyowa Hakko Kirin; Tremfya (guselkumab) / J&J; Stelara (ustekinumab) / J&J
COBRA: Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab (clinicaltrials.gov) – Sep 1, 2020 – P4; N=260; Not yet recruiting; Sponsor: LEO Pharma

 

llllllllll Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University
Last week, 26 items including the JAK inhibitor Boryeong tofacitinib were approved [Google translation] (Yakup Shinmoon) – Sep 1, 2020 – “…Boryeong tofacitinib tablet 5mg (Boryeong Pharmaceutical) containing tofacitinib aspartate as an oral JAK inhibitor used in the treatment of rheumatoid arthritis, etc. was approved…Boryeong tofacitinib tablet 5mg was approved as the first salt-modifying product of Gelzanz [sic] tablet (tofacitinib citrate), and unlike Gelzanz [sic] tablet 5mg, it has indications for rheumatoid arthritis and psoriatic arthritis, excluding ulcerative colitis. It is expected that the product will be available after November 2025, when the substance patent of Gelzance [sic] Tablet expires.”

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Weekly Top News – Psoriasis – August 24, 2020

August 24, 2020

llllllllll Otezla (apremilast) / Amgen
Long-term Study of Apremilast (CC-10004) in Pediatric Subjects from 6 Through 17 Years of Age with Moderate to Severe Plaque Psoriasis Estudio a largo plazo de apremilast (CC-10004) en pacientes pediátricos de 6 a 17 años con psoriasis en placas de moderada a grave (clinicaltrialsregister.eu) – Aug 18, 2020 – P3; N=140; Ongoing; Sponsor: Celgene Corporation`Amgen Inc.

 

llllllllll Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Kangzhe Pharmaceutical (00867): Tiralizumab injection, a psoriasis drug, was approved for clinical trials [Google translation] (Eastmoney.com) – Aug 19, 2020 – “CMS…announced that the Chinese State Drug pull natalizumab injection for management of drug clinical Office on 18 August 2020 issued by approved test notification form agreeing to carry out the treatment of moderate to evaluate Tildrakizumab in Chinese population…on the efficacy and safety of patients with severe plaque psoriasis.”

 

llllllllll serlopitant (JTS 661) / Menlo Therap
Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch) (clinicaltrials.gov) – Aug 18, 2020 – P3; N=558; Terminated; Sponsor: Menlo Therapeutics Inc.; Trial completion date: May 2021 –> Jun 2020; Active, not recruiting –> Terminated; Trial primary completion date: May 2021 –> Apr 2020; No longer pursuing development of serlopitant

 

llllllllll mirikizumab (LY3074828) / Eli Lilly
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2) (clinicaltrials.gov) – Aug 21, 2020 – P3; N=1484; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting –> Completed; Trial completion date: Dec 2020 –> May 2020

 

llllllllll Cosentyx (secukinumab) / Novartis
MATURE: Study of Efficacy and Safety of Secukinumab 2 mL Auto-injector (300 mg) in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Aug 18, 2020 – P3; N=122; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed

 

llllllllll Enstilar (calcipotriene/betamethasone dipropionate) / LEO Pharma
To Study Generic Calcipotriene and Betamethasone Dipropionate Topical Foam, 0.005%/0.064%, in the Treatment of Psoriasis Vulgaris (Plaque Psoriasis). (clinicaltrials.gov) – Aug 19, 2020 – P3; N=494; Completed; Sponsor: Glenmark Pharmaceuticals Ltd. India; Recruiting –> Completed; Trial completion date: Oct 2019 –> Mar 2020; Trial primary completion date: Oct 2019 –> Mar 2020

 

llllllllll BMS-986020 / BMS
[VIRTUAL] Discovery of BMS-986202, a clinical Tyk2 JH2 inhibitor for the treatment of autoimmune and inflammatory diseases (ACS-Fall 2020) – Aug 20, 2020 – Abstract #MEDI 33; Pres time: Aug 17, 2020; 08:00 AM – 11:40 AM; Location: On Demand Oral; “We have previously reported that targeting the Tyk2 pseudokinase domain (JH2) is an innovative and effective approach to selectively mediating the Tyk2-dependent signaling cascade, leading to a compound currently in phase III clinical development for the treatment of psoriasis. We now report the discovery and pre-clinical studies of the clinical backup Tyk2 JH2 inhibitor BMS-986202.”

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Weekly Top News – Psoriasis – August 17, 2020

August 17, 2020

llllllllll imsidolimab (ANB019) / AnaptysBio
AnaptysBio Announces Second Quarter 2020 Financial Results and Provides Pipeline Updates (AnaptysBio Press Release) – Aug 10, 2020 – “Treatment of GPP by imsidolimab is being evaluated in the GALLOP Phase 2 trial, where additional clinical data and a regulatory update is anticipated in the fourth quarter of 2020.”

 

llllllllll IMU-935 / Immunic
Immunic, Inc. Announces Closing of $103.5 Million Public Offering, including Full Exercise of Underwriters’ Option to Purchase Additional Shares (PRNewswire) – Aug 10, 2020 – “Immunic, Inc….announced the closing of an underwritten public offering of 5,750,000 shares of its common stock at a public offering price of $18.00 per share, which includes the exercise in full by the underwriters of their option to purchase an additional 750,000 shares….The Company intends to use the net proceeds of the offering to fund the ongoing clinical development of its three lead product candidates, IMU-838, IMU-935 and IMU-856…”

 

llllllllll BI 730357 / Boehringer Ingelheim
A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is (clinicaltrials.gov) – Aug 14, 2020 – P2; N=180; Recruiting; Sponsor: Boehringer Ingelheim; Active, not recruiting –> Recruiting; N=87 –> 180

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Weekly Top News – Psoriasis – August 3, 2020

August 3, 2020

llllllllll Stelara (ustekinumab) / J&J
U.S. Food and Drug Administration Approves STELARA (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis (PRNewswire) – Jul 30, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA® (ustekinumab) as a treatment for pediatric patients (6-11 years of age) who struggle with the skin lesions or plaques associated with moderate to severe plaque psoriasis (PsO)….STELARA is administered as an injection given under the skin, dosed four times per year after two starter doses….The FDA approval of STELARA for pediatric use is based on results from the CADMUS Junior study…”

 

llllllllll Cosentyx (secukinumab) / Novartis
Novartis Cosentyx receives EU approval for first-line systemic treatment in pediatric psoriasis (GlobeNewswire) – Aug 3, 2020 – “Novartis…today announced the European Commission (EC) has granted the approval for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 to

 

llllllllll bimekizumab (UCB4940) / UCB
UCB Half Year Report 2020 (StockHouse) – Jul 27, 2020 – “Operating expenses reached € 1 311 million (+14%; +13% CER) driven by…as well as launch preparations for bimekizumab for the treatment of psoriasis.”

 

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Data from P3 KEEPsAKE 1 trial (NCT03675308) for psoriatic arthritis in 2020 (AbbVie) – Aug 1, 2020 – Q2 2020 Results: Data from P3 trial (NCT03105102) for Crohn’s disease in Q4 2020/Q1 2021

 

llllllllll EDP1815 / Evelo Biosci
Evelo Biosciences Reports Second Quarter 2020 Financial Results and Business Highlights (BioSpace) – Jul 30, 2020 – “Achieved regulatory and ethics authorization for phase 2 dose ranging trial for EDP1815 in moderate psoriasis in the U.S., UK, and EU. The Company is on-track to initiate the trial in 3Q 2020.”

 

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi: Regulatory submissions for Crohn’s disease and psoriatic arthritis in 2021 (AbbVie) – Aug 1, 2020 – Q2 2020 Results

 

llllllllll bimekizumab (UCB4940) / UCB
Bimekizumab: Acceptance of regulatory submission for psoriasis at the end of Q3 2020 (UCB) – Jul 28, 2020 – H1 2020 Results 
[Screenshot]

 

llllllllll Stelara (ustekinumab) / J&J; Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms (clinicaltrials.gov) – Jul 27, 2020 – P3; N=132; Recruiting; Sponsor: AbbVie; Not yet recruiting –> Recruiting

 

llllllllll Remsima SC (infliximab biosimilar SC) / Celltrion
European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis (Businesswire) – Jul 27, 2020 – “Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima® (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis….We will accelerate the launch process on a country-by-country basis…Celltrion anticipates receiving approval of Remsima® SC in 97 countries, including 31 countries in Europe.”

 

llllllllll Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Almirall: Sustained performance of key growth drivers and excellent progress on pipeline in H1 despite negative impact of COVID-19 (PRNewswire) – Jul 27, 2020 – “Key growth drivers continue to show positive results. Ilumetri® performed strongly despite a decrease in new patient initiations during the COVID-19 pandemic…These assets, together with Lebrikizumab, have the potential to deliver an exciting new era of growth for Almirall.”

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Weekly Top News – Psoriasis – July 20, 2020

July 20, 2020

llllllllll Tremfya (guselkumab) / J&J
TREMFYA (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis (PRNewswire) – Jul 14, 2020 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for adult patients with active psoriatic arthritis (PsA)…TREMFYA is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA. The safety and efficacy of TREMFYA in PsA have been demonstrated in two pivotal Phase 3 clinical trials.”

llllllllll mirikizumab (LY3074828) / Eli Lilly; Cosentyx (secukinumab) / Novartis
Lilly’s Mirikizumab Superior to Cosentyx (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis (Eli Lilly Press Release) – Jul 17, 2020 – P3, N=1,443; OASIS-2 (NCT03535194); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today that mirikizumab…met the primary and all key secondary endpoints versus placebo at Week 16 (superiority) and all key secondary endpoints versus Cosentyx (secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority) in the OASIS-2 study….’We are pleased with the positive results observed in the mirikizumab psoriasis development program (OASIS). Mirikizumab has the potential to be a meaningful treatment option for people living with psoriasis,’ said Andrew Blauvelt, M.D….Lilly expects topline results for the Phase 3 induction data in ulcerative colitis in the spring of 2021 and for the Phase 3 Crohn’s data in 2022; Lilly will submit data from OASIS-1 and 2 to regulatory authorities around the world.”

llllllllll HB0017 / Zhejiang Huahai Pharma
Huahai Pharmaceutical (600521.SH): HB0017 injection project approved for two new indications [Google translation] (Securities Star) – Jul 14, 2020 – “Huahai Pharmaceutical (600521.SH) announced that recently, the company’s subsidiaries Huabo Biomedical Technology (Shanghai) Co., Ltd. (‘Huabo Bio’) and Shanghai Huaaotai Biopharmaceutical Co., Ltd. (‘Hua’aotai’) received the ‘Clinical Trial Notification’ for the two new indications of the HB0017 injection project approved by the State Drug Administration (‘SFDA’)…HB0017 injection….Psoriatic arthritis…acceptance number: CXSL2000076….Ankylosing spondylitis…acceptance number: CXSL2000081.”

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Jul 17, 2020 – P3; N=157; Completed; Sponsor: AbbVie; Active, not recruiting –> Completed

llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Xeljanz (tofacitinib) / Pfizer, Marche Polytechnic University; Humira (adalimumab) / Eisai, AbbVie
Pharma’s TV ad spending level sets in June, with AbbVie, Sanofi and Regeneron leading the way (Fierce Pharma) – Jul 16, 2020 – “The top 10 TV buyers’ total spending was $141 million, almost the same as the $140 million from June 2019….Sanofi and Regeneron’s type 2 anti-inflammatory med Dupixent at $13.1 million in June TV media buys….1. Humira: Total estimated spending: $44.3 million (up from $32.5 million in May); 3. Xeljanz: Total estimated spending: $12.5 million (up from $11.5 million in May); 9. Rinvoq: Total estimated spending: $9 million (down from $12.9 million in May); 10. Skyrizi: Total estimated spending: $8.8 million (up from $8.7 million in May).”

llllllllll Cosentyx (secukinumab) / Novartis
pINPOINt: A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD) (clinicaltrials.gov) – Jul 14, 2020 – P3; N=90; Recruiting; Sponsor: Novartis Pharmaceuticals; Suspended –> Recruiting

llllllllll AVT02 (adalimumab biosimilar) / Cipla, Alvotech
Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jul 15, 2020 – P3; N=448; Recruiting; Sponsor: Alvotech Swiss AG; Not yet recruiting –> Recruiting

llllllllll BI 730357 / Boehringer Ingelheim
This Study is Done in Patients With Plaque Psoriasis and Tests How Well They Tolerate BI 730357 and How Effective it is (clinicaltrials.gov) – Jul 17, 2020 – P2; N=270; Recruiting; Sponsor: Boehringer Ingelheim; Active, not recruiting –> Recruiting; N=178 –> 270; Trial primary completion date: Oct 2019 –> Jun 2021

llllllllll Otezla (apremilast) / Amgen
APRIL: Observational Study of Apremilast in Patients With Psoriasis in The Netherlands (clinicaltrials.gov) – Jul 16, 2020 – P=N/A; N=154; Completed; Sponsor: Amgen; Active, not recruiting –> Completed

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Weekly Top News – Psoriasis – July 13, 2020

July 13, 2020

imsidolimab (ANB019) / AnaptysBio
AnaptysBio Announces Orphan Drug Designation of Imsidolimab For Treatment of Generalized Pustular Psoriasis (GlobeNewswire) – Jul 8, 2020 – “AnaptysBio, Inc….today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for imsidolimab…for the treatment of patients with GPP….Treatment of GPP by imsidolimab is being evaluated in the GALLOP Phase 2 trial, where additional clinical data and a regulatory update is anticipated in the second half of 2020.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab Compared to Placebo in Subjects With Active Psoriatic Arthritis I (INSPIRE 1) (clinicaltrials.gov) – Jul 7, 2020 – P3; N=472; Recruiting; Sponsor: Sun Pharma Global FZE; Not yet recruiting –> Recruiting

 

Avsola (infliximab-axxq) / Amgen
Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym (GaBI) – Jul 10, 2020 – “Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab Compared to Placebo in Anti-TNF naïve Subjects With Active Psoriatic Arthritis II (INSPIRE 2) (clinicaltrials.gov) – Jul 7, 2020 – P3; N=292; Recruiting; Sponsor: Sun Pharma Global FZE; Not yet recruiting –> Recruiting

 

Stelara (ustekinumab) / J&J
Joint Letter to CMS Advocates Against Adding Stelara to Self-Administered Drug List (The Rheumatologist) – Jul 6, 2020 – “Most recently, the ACR partnered with the Coalition of State Rheumatology Organizations and the Arthritis Foundation to send a letter to the Centers for Medicare & Medicaid Services requesting that it review the Medicare Administrative Contractors’ (MACs) decision to add this drug to the SAD list. Keeping Stelara off the list is important to ensure continued access for patients who can’t self-administer….Implementation is now planned for 45 days after the end of the public health emergency….ACR advocacy efforts will continue to prioritize protecting patient access to Stelara under Medicare Part B.”

 

Hulio (adalimumab biosimilar) / Mylan, Fujifilm Kyowa Kirin Biologics
Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio (adalimumab-fkjp) (PRNewswire) – Jul 9, 2020 – “Mylan…and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp)…for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations….In accordance with its patent license agreement with AbbVie, Mylan will be able to launch Hulio in the U.S. during July 2023.”

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Weekly Top News – Psoriasis – July 6, 2020

July 6, 2020

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Study of Subcutaneous Risankizumab Injection to Assess Change in Palmoplantar Pustulosis Area and Severity Index [PPPASI] in Adult Japanese Participants With Palmoplantar Pustulosis (clinicaltrials.gov) – Jun 30, 2020 – P3; N=116; Not yet recruiting; Sponsor: AbbVie

 

Siliq (brodalumab) / Bausch Health, LEO Pharma, Kyowa Hakko Kirin
Efficacy and safety of brodalumab in adolescents from 12 to 17 years of age with moderate-to-severe plaque psoriasis (clinicaltrialsregister.eu) – Jun 30, 2020 – P3; N=120; Sponsor: LEO Pharma A/S

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharmaceutical Industries receives Japan MHLW approval for Ilumya (Business Standard) – Jun 29, 2020 – “Sun Pharmaceutical Industries announced that one of its wholly-owned subsidiaries has received approval from the Ministry of Health, Labour and Welfare (MHLW), Japan for Ilumya (tildrakizumab) for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies.”

 

AVT02 (adalimumab biosimilar) / Cipla, Alvotech
Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – Jul 1, 2020 – P3; N=448; Not yet recruiting; Sponsor: Alvotech Swiss AG

 

bimekizumab (UCB4940) / UCB; Humira (adalimumab) / Eisai, AbbVie
BE OPTIMAL: A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Jul 1, 2020 – P3; N=840; Recruiting; Sponsor: UCB Biopharma SRL; Suspended –> Recruiting

 

bimekizumab (UCB4940) / UCB
BE COMPLETE: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Jul 1, 2020 – P3; N=390; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Suspended –> Recruiting

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