Dermatology

AbbVie (NYSE:ABBV) has announced that FDA has approved Skyrizi (risankizumab-rzaa) as the first interleukin-23 (IL-23) inhibitor to treat adults with moderately to severely active Crohn’s disease (CD). Skyrizi is also FDA-approved as a treatment for moderate to severe plaque psoriasis and active psoriatic arthritis. IL-23 inhibitors have surged in popularity recently, given their ability to…

The FDA has announced that it has approved Lilly’s Olumiant (baricitinib) oral tablets to treat adults with severe alopecia areata, a form of baldness resulting from the body attacking its hair follicles. Manifesting as patchy baldness, alopecia areata affects more than 300,000 people in the U.S. The incidence of alopecia areata is growing. “Access to…

Sol-Gel (Nasdaq:SLGL) and Galderma have announced that it has won FDA approval for Epsolay cream, a proprietary topical formulation of benzoyl peroxide, 5%, for treating inflammatory rosacea lesions. Rosacea is a common condition, but experts have struggled to estimate its global prevalence. A 2018 estimate in the British Journal of Dermatology concluded that the condition affects between…

Eli Lilly (NYSE:LLY) has announced promising results from a Phase 3 study of patients with moderate-to-severe atopic dermatitis (AD). At 16 weeks, 70% of patients with moderate-to-severe atopic dermatitis (AD) taking both lebrikizumab and standard-of-care topical corticosteroids (TCS) achieved at least 75% improvement in overall disease severity (EASI-75*) in the ADhere trial. The company made…

A recent comprehensive network meta-analysis (NMA) concluded that Tremfya (guselkumab) from Janssen (NYSE:JNJ) ranked highest for the overall level of skin clearance among 23 treatment regimens for active psoriatic arthritis (PsA). The NMA drew on data from 33 Phase 3 randomized clinical trials. Of those, 15 were targeted PsA therapies such as the IL-23p19 inhibitors such…

Having recently sold an equity stake in Samsung Bioepis for up to $2.3 billion, Biogen (NSDQ:BIIB) has announced a licensing deal with Xbrane Biopharma (STO:XBRANE), a Swedish biosimilar developer. The agreement relates to the development of Xcimzane, a preclinical monoclonal antibody referencing Cimzia (certolizumab pegol) from UCB. Having first won FDA approval in 2018 for moderate to…

Pfizer (NYSE:PFE) has announced that the FDA has approved the oral Janus kinase 1 inhibitor Cibinqo (abrocitinib) for adults with refractory, moderate-to-severe atopic dermatitis (AD). In 2020, Pfizer CEO Dr. Albert Bourla projected that Cignqo would generate $3 billion in peak sales. In 2021, SVB Leerink projected the drug would generate $2 billion in sales…

FDA has approved Rinvoq (upadacitinib) from AbbVie (NYSE:ABBV) to treat moderate to severe atopic dermatitis in individuals at least 12 years old. AbbVie anticipates 2025 risk-adjusted sales for Rinvoq to top $7.5 billion. The most common type of eczema, atopic dermatitis, can be managed with various therapies, including corticosteroids, topical calcineurin inhibitors and immunosuppressants. Nevertheless, the…

The FDA has approved Incyte’s (NSDQ:INCY) ruxolitinib, a cream for short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis (eczema). As many as 15 million Americans have atopic dermatitis, according to the Cleveland Clinic. In addition, the NIH estimates that the condition affects 30 million Americans, predominantly children and adolescents. The labeling for ruxolitinib (Opzelura) constrains its…

Janssen’s Tremfya (guselkumab) generally had higher efficacy in treating moderate-to-severe psoriasis than Cosentyx (secukinumab) from Novartis, according to recent data published in the Journal of Dermatological Treatment.  In the 48-week Phase 3 ECLIPSE study, a greater number of guselkumab recipients achieved at least a 90% and 100% improvement from baseline in Psoriasis Area and Severity…

Pfizer (NYSE: PFE) recently announced that its once-daily oral Janus kinase 1 (JAK1) inhibitor abrocitinib bested Sanofi’s Dupixent (dupilumab) in a Phase 3 study focused on moderate to severe atopic dermatitis (AD). Meanwhile, Sanofi (EPA:SAN) announced that a Dupixent pivotal trial met its primary and secondary endpoints, making it the first biologic to demonstrate significant…

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…

Two decades ago, psoriasis was a poorly understood condition. Treatment options for severe psoriasis included powerful immunosuppressant agents such as methotrexate and cyclosporin that can have significant side effects. But the fact those immunosuppressant drugs were effective at treating psoriasis helped pave the way to use biologics to treat the condition. The experience “really taught…