A Pfizer Inc (PFE.N) ointment to treat mild to moderate cases of the itchy skin condition eczema, or atopic dermatitis, won U.S. approval for use in patients aged two years and older, the Food and Drug Administration said on Wednesday.
Atopic dermatitis, a chronic inflammatory skin disease, 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 acquired the drug through its $5.2 billion purchase of Anacor Pharmaceuticals earlier this year, has estimated potential annual peak sales for Eucrisa of about $2 billion.
Eucrisa will carry a wholesale price of $580 for a 60 gram (2 ounce) tube and be available by the end of January, Pfizer said. The wholesale cost does not take into account discounts or rebates the company may offer insurers and pharmacy benefit managers.
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.
While dupilumab appears to be more effective, BMO Capital Markets analyst Alex Arfaei said in a research note, "Eucrisa will likely have a dosing, safety and price advantage; attractive attributes for dermatologists."
He sees the treatment reaching annual peak sales of about $2 billion by 2023.
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.
Pfizer shares were little changed, closing at $32.82 on the New York Stock Exchange.
(Reporting by Bill Berkrot in New York and Akankshita Mukhopadhyay in Bengaluru; Editing by James Dalgleish and Alan Crosby)