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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