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


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.”


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


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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