Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.
U.S. FDA Expands Regulatory Approvals for LEO Pharma’s Enstilar Foam and Taclonex Topical Suspension in Treatment of Plaque Psoriasis
LEO Pharma Inc announced the U.S. Food and Drug Administration expanded the approved indication for Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 and older. Additionally, the FDA approved Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension in the topical treatment of scalp and body plaque psoriasis in patients 12 years and older.
Bristol-Myers Squibb Co. offered to divest Celgene Corp.’s psoriasis treatment Otezla to allay concerns raised by the U.S. competition regulator, and pushed back the closing of their $74 billion deal.
The U.S. FDA approved AbbVie Inc.’s Skyrizi as a treatment for plaque psoriasis at a time when the company’s blockbuster psoriasis medicine Humira faces patent pressures.
Eli Lilly and Co. said the company’s psoriatic arthritis (PsA) drug Taltz was found to be more effective than the world’s best-selling prescription medicine, AbbVie Inc.’s Humira, in a late-stage study.
Johnson & Johnson said the company’s drug Tremfya was more effective than Novartis AG’s rival medicine Cosentyx, and met the main goal of a late-stage study in adults with moderate-to-severe plaque psoriasis.
Celgene Announces Phase 3 STYLE Study Of Otezla In Moderate-To-Severe Scalp Psoriasis Met Primary Endpoint
Celgene Corporation announced results from the phase 3 STYLE study, which showed that Otezla (apremilast) 30 mg twice daily achieved a highly statistically significant improvement in the primary endpoint of the Scalp Physician’s Global Assessment response at week 16 compared with placebo.
Bausch Health, formerly Valeant Pharmaceuticals, received tentative U.S. approval to market the plaque psoriasis lotion Bryhali.
Lilly Announces Initiation of IXORA-R Head-to-Head Trial Comparing Taltz and Tremfya in Patients with Moderate-to-Severe Plaque Psoriasis
Eli Lilly and Company announced today the initiation of the IXORA-R head-to-head clinical trial, designed to evaluate superiority between Taltz (ixekizumab) and Tremfya (guselkumab) in adult patients with moderate-to-severe plaque psoriasis.
Months after tapping GlaxoSmithKline dermatology division executive David Rubenstein as its new chief scientific officer, Vivek Ramaswamy’s Dermavant Sciences returned to the pharma giant to acquire a Phase III-ready psoriasis treatment.