The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.
The U.S. Food and Drug Administration approved Novartis’ blockbuster drug Cosentyx (secukinumab) for pediatric patients aged 6 years and older with moderate-to-severe plaque psoriasis. The new approval for Cosentyx marks the first for a pediatric patient population in the United States.
During the Digestive Disease Week meeting, AbbVie presented late-breaking data analyses that showed both doses of Skyrizi met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo in two Phase III studies. The Lancet published results from pivotal global Phase III clinical trials – Measure Up 1, Measure Up 2 and AD Up – evaluating Rinvoq (upadacitinib) in adults and adolescents with mild to severe atopic dermatitis who were candidates for systemic treatment.
Clarivate published the company’s annual “Drugs to Watch” list, and cited several medicines that the analysts expect to be blockbusters – projected to bring in $1 billion in sales annually.
Dermavant Sciences announced positive safety and efficacy results from a planned interim analysis of the company’s PSOARING 3 safety study of tapinarof, a novel, once-daily therapeutic aryl hydrocarbon receptor modulating agent steroid-free cream.
Bristol Myers Squibb announced positive data from POETYK PSO-2, the second Phase III trial of deucravacitinib for moderate to severe plaque psoriasis, evaluated against placebo and Amgen’s Otezla (apremilast).
Bristol Myers Squibb’s experimental psoriasis drug deucravacitinib (BMS-986165) beat out Amgen’s Otezla (apremilast) in the POETYK PSO-1 Phase III clinical trial.
Dermavant Sciences announced positive data from two Phase III clinical trials evaluating tapinarof cream 1% in adults with plaque psoriasis.
The U.S. Food and Drug Administration approved MC2 Therapeutics’ Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for once-daily topical treatment of plaque psoriasis in adults 18 years of age or older.
Eli Lilly’s experimental treatment mirikizumab for plaque psoriasis beat out Novartis’ vaunted drug Cosentyx in a Phase III comparison study.