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Category: Psoriasis

Weekly Top News – Psoriasis – May 13, 2019

May 13, 2019

Cosentyx (secukinumab) / Novartis
SUBCUTANEOUS SECUKINUMAB 300MG AND 150MG PROVIDES SUSTAINED INHIBITION OF RADIOGRAPHIC PROGRESSION IN PSORIATIC ARTHRITIS OVER 2 YEARS: RESULTS FROM THE PHASE 3 FUTURE-5 TRIAL (EULAR 2019) – May 10, 2019 – Abstract #LB0006; Pres time: Jun 15, 2019; 08:18 AM – 08:24 AM; Location: Hall 7B; No abstract available.

 

Taltz (ixekizumab) / Eli Lilly
IXEKIZUMAB IMPROVES THE SIGNS AND SYMPTOMS OF PSORIATIC ARTHRITIS REGARDLESS OF SEX, DURATION OF DISEASE, OR BODY MASS INDEX IN TWO RANDOMIZED, PHASE 3 CLINICAL TRIALS (EULAR 2019) – May 10, 2019 – Abstract #FRI0430; Pres time: Jun 14, 2019; No abstract available.

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE, PHASE 2B STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF TILDRAKIZUMAB, A HIGH-AFFINITY ANTI–INTERLEUKIN-23P19 MONOCLONAL ANTIBODY, IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (EULAR 2019) – May 10, 2019 – Abstract #LB0002; Pres time: Jun 12, 2019; 05:35 PM – 05:45 PM; Location: Hall 6; No abstract available.

 

Idacio (adalimumab biosimilar) / Fresenius Kabi
Eye on Pharma: Fresenius Kabi launches biosimilar adalimumab, Idacio (Center for Biosimilars) – May 6, 2019 – “Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.”

 

Humira (adalimumab) / Eisai, AbbVie; bimekizumab (UCB4940) / UCB
BE OPTIMAL: A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – May 7, 2019 – P3; N=840; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Not yet recruiting –> Recruiting

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Weekly Top News – Psoriasis – May 6, 2019

May 6, 2019

Psoriasis

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
European Commission approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis (AbbVie Press Release) – Apr 30, 2019 – “AbbVie…today announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. SKYRIZI (150 mg) is approved to be administered by two subcutaneous injections every 12 weeks…This approval allows for the marketing of SKYRIZI in all member states of the European Union, as well as Iceland, Liechtenstein and Norway….SKYRIZI received EC approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance…”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Long-term safety of tildrakizumab in patients with moderate-to-severe psoriasis: incidence of major adverse cardiovascular events through 148 weeks from reSURFACE 1 and reSURFACE 2 phase 3 trials (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 03:10 PM – 03:20 PM; Location: BROWN 3; No abstract available.

 

Otezla (apremilast) / Celgene
A Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy (clinicaltrials.gov) – Apr 29, 2019 – P3b; N=150; Not yet recruiting; Sponsor: Celgene

 

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) – Apr 30, 2019 – P3; N=390; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Not yet recruiting –> Recruiting

 

pegcantratinib (SNA-120) / Bio3 Research, Sienna
SNA-120, A Novel Topical Non-steroidal Therapy for Psoriasis and Associated Pruritus that Targets the NGF/TrkA Pathway: Results from a Multicenter Phase 2b Study (WCD 2019) – May 3, 2019 – Pres time: Jun 15, 2019; 10:35 AM – 10:45 AM; Location: YELLOW 3; No abstract available.

 

Otezla (apremilast) / Celgene
DISCREET: An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis (clinicaltrials.gov) – May 1, 2019 – P3; N=332; Recruiting; Sponsor: Celgene; Not yet recruiting –> Recruiting

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Risankizumab is Associated With Low and Consistent Infection Rates in Patients With Moderate-to-Severe Psoriasis: Analysis of Short-Term and Long-Term Pooled Clinical Trial Data (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 02:50 PM – 03:00 PM; Location: BROWN 3; No abstract available.

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi pricing: Wholesales acquisition cost of $59,000/year for maintenance dose and $88,500/year for therapy of new patients (UBS) – May 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67166772; Page no: 1; REPORT TITLE: “AbbVie Inc.- First read: AbbVie “Skyrizi approval is incrementally positive; Clean …”; AUTHOR: Jacob, Navin, et al; DATE: 04/23/2019

 

mirikizumab (LY3074828) / Eli Lilly
Improvement in Psoriasis Scalp Severity Index (PSSI) during Maintenance Treatment with Mirikizumab (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 03:50 PM – 04:00 PM; Location: BROWN 3; No abstract available.

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Weekly Top News – Psoriasis – April 29, 2019

April 29, 2019

BMS-986165 / BMS

An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) – Apr 23, 2019 – P3; N=80; Recruiting; Sponsor: Bristol-Myers Squibb
Clinical • New P3 trial

 

Cosentyx (secukinumab) / Novartis

Cosentyx: 5-year data from P3 FUTURE 2 trial (NCT01752634) for psoriatic arthritis at ACR (November 8-13, 2019) (Novartis) – Apr 24, 2019 – Q1 2019 Results: 2-year data from P3 FUTURE 5 trial (NCT02404350) for psoriatic arthritis at EULAR (June 12- 15, 2019)
P3 data
[Screenshot]

 

Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen

Samsung Bioepis wins FDA approval for biosimilar (Yonhap News Agency) – Apr 26, 2019 – “…Samsung Bioepis…has won approval from the U.S. Food and Drug Administration to sell one of its biosimilar in the United States. Etanercept — a biosimilar referencing the immunology drug Enbrel developed by U.S.-based Amgen Inc. — will be used in the treatment of rheumatoid arthritis and psoriatic arthritis, the company said in a press release. However, it is undecided yet when Etanercept will go on sale in the U.S. as the patent for Enbrel is to expire in 2029.”
BLA • Patent

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim

AbbVie expands immunology portfolio in the U.S. with FDA approval of Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis (PRNewswire) – Apr 23, 2019 – “AbbVie…announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy….The approval of SKYRIZI is supported by results from AbbVie’s global Phase 3 psoriasis program, which assessed the safety and efficacy of SKYRIZI in adults with moderate to severe plaque psoriasis across four randomized, placebo and/or active-controlled pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent.”
BLA

 

Humira (adalimumab) / Eisai, AbbVie

The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis (clinicaltrials.gov) – Apr 25, 2019 – P3; N=330; Not yet recruiting; Sponsor: Sinocelltech Ltd.
Clinical • New P3 trial

 

Cosentyx (secukinumab) / Novartis

Cosentyx: Launch in China for psoriasis in H2 2019 (Novartis) – Apr 24, 2019 – Q1 2019 Results
Launch non-US
[Screenshot]

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin; Stelara (ustekinumab) / J&J

New data show that LEO Pharma’s Kyntheum (brodalumab) sustains PASI 100 scores longer than ustekinumab for people with moderate-to-severe plaque psoriasis (Businesswire) – Apr 25, 2019 – P3, N=1,831; AMAGINE-2 (NCT01708603); P3, N=1,881; AMAGINE-3 (NCT01708629); Sponsor: Amgen; “LEO Pharma…today announced that new data presented this week at the 6th Congress of the Skin Inflammation and Psoriasis International Network (SPIN) in Paris demonstrate that more patients with moderate-to-severe psoriasis who received treatment with brodalumab maintained a PASI (Psoriasis Area Severity Index) 100 score for longer than those who were treated with ustekinumab over 52 weeks.”
Retrospective data

 

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Weekly Top News – Psoriasis – April 22, 2019

April 22, 2019

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Health Canada approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis (Canada Newswire) – Apr 18, 2019 – “AbbVie…announced today that Health Canada has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy….SKYRIZI received Health Canada approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.”
Canadian regulatory

 

KD025  / Kadmon
KD025 US launch estimate: 2021 in plaque psoriasis (Jefferies) – Apr 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 66898956; Page no: 4; REPORT TITLE: “Kadmon Holdings Inc – Q4 ’18: Pivotal study readout for KD025 in cgvhd expected at YE ’19”; AUTHOR: Amin, Biren, et al; DATE: 03/08/2019
Launch US

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
NICE publishes final recommendation for Ilumetri (Pharmafield) – Apr 17, 2019 – “NICE has published final recommendation for ILUMETRI (Tildrakizumab), as a cost-effective option for adults with moderate-to-severe plaque psoriasis.”
NICE

 

Tremfya (guselkumab) / J&J
A brighter future for psoriasis patients in Egypt (Egypt Today) – Apr 15, 2019 – “Ministry of health approved the first biological treatment of moderate to severe plaque psoriasis patients….Tremfya is the first biologic treatment approved by the ministry of health under resolution 820, which allows the registration of FDA-approved treatments and European EMEA in a short period of up to three months, which confirms the ministry’s mission to provide advanced biological treatments that help to heal the Egyptian patient as soon as possible.”
Non-US regulatory

 

Enbrel (etanercept) / Takeda, Pfizer, Amgen
A RANDOMIZED, PHASE 3, DOUBLE-BLIND TRIAL EXAMINING METHOTREXATE AND ETANERCEPT AS MONOTHERAPY OR IN COMBINATION FOR TREATING PSORIATIC ARTHRITIS: A COMPARISON OF THE COMPOSITE MEASURES USED TO EVALUATE DISEASE ACTIVITY (EULAR 2019) – Apr 16, 2019 – Abstract #OP0111; Pres time: Jun 13, 2019; 10:50 AM – 11:00 AM; Location: Hall 8; No abstract available.
Clinical • Monotherapy • P3 data

 

Cosentyx (secukinumab) / Novartis
SECUKINUMAB IMPROVES AXIAL MANIFESTATIONS IN PATIENTS WITH PSORIATIC ARTHRITIS AND INADEQUATE RESPONSE TO NSAIDS: PRIMARY ANALYSIS OF THE MAXIMISE TRIAL (EULAR 2019) – Apr 16, 2019 – Abstract #OP0235; Pres time: Jun 14, 2019; 11:00 AM – 11:10 AM; Location: Hall 7A; No abstract available.
Clinical

 

Taltz (ixekizumab) / Eli Lilly
IXEKIZUMAB IMPROVES SIGNS AND SYMPTOMS OF PSORIATIC ARTHRITIS IN PATIENTS WHO HAVE HAD INADEQUATE RESPONSE TO 1 OR 2 TUMOR NECROSIS FACTOR INHIBITORS (EULAR 2019) – Apr 16, 2019 – Abstract #OP0110; Pres time: Jun 13, 2019; 10:40 AM – 10:50 AM; Location: Hall 8; No abstract available.
Clinical

 

Cosentyx (secukinumab) / Novartis
MACHINE LEARNING TOOLS IDENTIFY PATIENT CLUSTERS AND SWOLLEN AND TENDER JOINT CORRELATION PATTERNS IN A LARGE DATABASE FROM THE SECUKINUMAB PSORIATIC ARTHRITIS CLINICAL DEVELOPMENT PROGRAM (EULAR 2019) – Apr 16, 2019 – Abstract #OP0114; Pres time: Jun 13, 2019; 11:20 AM – 11:30 AM; Location: Hall 8; No abstract available.
Clinical

 

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Weekly Top News – Psoriasis – April 9, 2019

April 9, 2019

Idacio (adalimumab biosimilar) / Fresenius Kabi
Fresenius Kabi receives European Commission approval for adalimumab biosimilar Idacio (Fresenius Kabi Press Release) – Apr 3, 2019 – “Fresenius Kabi…announced today that the European Commission (EC) granted marketing authorization for IDACIO®, an adalimumab biosimilar, for all indications of the reference medicine.”
European regulatory

 

bimekizumab (UCB4940) / UCB
Bimekizumab clinical trial estimate: Data from P3 BE SURE trial (NCT03412747) for psoriasis in H1 2019 (Infinata) – Apr 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 66478978; Page no: 2; REPORT TITLE: “UCB S.A. – Company report”; AUTHOR: Infinata, et al; DATE: 03/05/2019
P3 data

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasi (clinicaltrials.gov) – Apr 1, 2019 – P3; N=136; Not yet recruiting; Sponsor: Sun Pharma Global FZE
Clinical • New P3 trial

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Risankizumab regulatory estimate: PDUFA date for psoriasis on April 26, 2019 (William Blair) – Apr 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67011697; Page no: 5; REPORT TITLE: “William Blair Biopharma Catalyst watch second quarter 2019”; AUTHOR: Xu, Yu Katherine, et al; DATE: 03/29/2019
PDUFA date

 

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) – Apr 1, 2019 – P3; N=390; Not yet recruiting; Sponsor: UCB Biopharma S.P.R.L.
Clinical • New P3 trial

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis (clinicaltrials.gov) – Apr 1, 2019 – P3; N=146; Not yet recruiting; Sponsor: Sun Pharma Global FZE
Clinical • New P3 trial

 

Cosentyx (secukinumab) / Novartis
Novartis first-in-class Cosentyx approved in China for psoriasis patients (Novartis Press Release) – Apr 2, 2019 – “Novartis…announced today that the China Health Authority NMPA approved Cosentyx® (secukinumab), the first-in-class interleukin-17A (IL-17A) inhibitor for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy…Positive China data presented recently makes us hopeful for the clinical use of secukinumab in China.”
Non-US regulatory

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