FDA approves Pfizer ointment for itchy skin condition
The U.S. Food and Drug Administration on Wednesday said it approved Pfizer Inc's (PFE.N) ointment to treat mild to moderate cases of the itchy skin condition eczema, or atopic dermatitis, for use in patients aged two years and older.
Atopic dermatitis is the most common of the many types of eczema, typically beginning in childhood and possibly lasting through adulthood. The condition causes red, scaly and crusted bumps on the skin that can be extremely itchy.
The topical drug, crisaborole, will be sold under the brand name Eucrisa, the FDA said.
Pfizer, which bought Anacor Pharmaceuticals for $5.2 billion this year to add the drug to its portfolio, has estimated potential annual peak sales for Eucrisa of about $2 billion.
In clinical trials that led to the drug's approval, many patients who received Eucrisa experienced clear or almost clear skin after 28 days of treatment. The most common side effect was application site pain, including burning or stinging, the agency said.
Atopic dermatitis is considered to be a large market and an unmet need.
Regeneron Pharmaceuticals (REGN.O) and Sanofi (SASY.PA) are awaiting an approval decision for their injectable drug dupilumab for more severe cases of atopic dermatitis, which patients have described as being like having a permanent case of poison ivy that leads to intense scratching and skin damage.
Pfizer shares were up 0.4 percent at $32.98.