Pfizer's Eucrisa snags FDA approval
- The lead product that Pfizer picked up through its $5.2 billion acquisition of Anacor in May has secured a green light from the Food and Drug Administration.
- Eucrisa (crisaborole) is now approved by the FDA for the treatment of mild to moderate eczema (atopic dermatitis) in adults and children aged two years and older. The eczema market could be worth $7.3 billion by 2024, according to GlobalData.
- The approval is based on two studies in more than 1500 patients. In the two studies, 32.8% and 31.4% of patients, respectively, were clear or almost clear after 28 days after using Eucrisa, compared with 25.4% or 18.0% who used the non-medicated ointment (vehicle). The most common side effect was burning or stinging.
Eczema, also known as atopic dermatitis, affects up to 18 million adults and children in the U.S., with around 90% having a mild to moderate form. Treatment includes moisturizing, corticosteroids and topical immunomodulators.
Eucrisa takes a different approach — it is a non-steroidal anti-inflammatory drug (NSAID). According to the company this is the first new prescription treatment option for patients with mild to moderate disease for more than a decade, and the first non-steroidal topical monotherapy that inhibits PDE-4 in the skin.
"Today’s approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis," said Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER).
Pfizer has been on a spending spree this year and gained Eucrisa when it bought Anacor Pharmaceuticals in May in a $5.2 billion deal .Eucrisa was Anacor's lead candidate. While the company has inflammation and immunology products in the pipeline and on the market, this acquisition provided a near-term launch.
Other non-steroidal eczema drugs heading towards the market include Sanofi and Regeneron's Dupixent (dupilumab), a monoclonal antibody in Phase 3 for severe eczema. A report from Reuters also flags up drugs earlier in pipelines, including Roche's lebrikizumab, AstraZeneca's tralokinumab, and Celgene's apremilast, which could be the first oral treatment for eczema.
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