Pfizer’s eczema drug Eucrisa approved
Pfizer has gained FDA approval for Eucrisa, a new eczema treatment which could achieve peak annual sales of $2 billion a year.
The drug is significant because it is the first non-steroidal therapy for the skin condition in more than 15 years.
Pfizer acquired the Eucrisa (crisaborole) when it bought its developer, Anacor in May this year for $5.2 billion.
Eucrisa gained approval based on two trials involving over 1,500 patients with mild-to-moderate eczema, showing the ointment was more effective than placebo in achieving clear or almost clear skin after 28 days' treatment.
The drug comes with a hefty price of $580 for a 60g tube before any discounts or rebates, and is expected to hit the market early next year.
An estimated 18 - 25 million people suffer from eczema in the US, with more cases being diagnosed in children than ever before.
The drug is a phosphodiesterase-4 (PDE4) inhibitor targeting an anti-inflammatory mechanism already exploited by treatments for asthma, COPD and psoriasis.
These include Celgene’s Otezla, which is already approved for psoriasis, but is now also in development for eczema.
Sanofi and Regeneron have an injectable drug Dupixent (dupilumab), but this is more acute forms atopic dermatitis. Roche and AstraZeneca also have antibody-based eczema treatments in phase 2 trials.
While existing topical steroid treatments are low cost, they can have serious side-effects, most notably a thinning of the skin.
Analysts believe the Eucrisa’s advantages will help it be taken up quickly in the US, though Pfizer may well face some concerted opposition from payers on its price.