Score a big win for Pfizer and its $4.5 billion buyout of Anacor Pharmaceuticals. The FDA Wednesday approved Anacor's eczema treatment that is projected to be a $2 billion blockbuster.
The FDA approved Eucrisa (crisaborole) ointment to treat mild to moderate atopic dermatitis, better know as eczema, in patients two years and older. The condition results in red, scaly and extremely itchy crusted bumps.
The phosphodiesterase 4 (PDE-4) inhibitor was tested in two placebo-controlled trials with a total of 1,522 participants that ranged in age from two to 79 years. The FDA said overall, participants receiving Eucrisa achieved greater response with clear or almost clear skin after 28 days of treatment. The FDA said the most common side effect was burning or stinging when the gel was applied.
Pfizer pointed out that approximately 90% of people living with AD have the mild to moderate form of the condition. “The approval of Eucrisa is great news for the children and adults suffering from mild to moderate eczema, a community that has not had a new prescription treatment for more than 10 years,” Albert Bourla, group president, Pfizer Innovative Health, said in a statement.
Pfizer closed its buyout of Anacor in June, a bite-sized deal it knocked off shortly after it halted its planned buyout of Allergan. The company abandoned that plan after tax rule changes made them it less appealing.
Anacor, meanwhile, already had an approved drug in Kerydin, an anti-fungal drug that is marketed in the U.S. by Novartis’ generics unit Sandoz. The big draw for Pfizer, however, was the non-steroidal topical gel crisaborole, which Pfizer has said would be the first new eczema treatment approved in 15 years.
The FDA pointed out that eczema is a general term for several types of inflammation of the skin, with atopic dermatitis being the most common. It is a significant market that others are working to address as well.
Partners Sanofi and Regeneron in September won priority review from the FDA for dupilumab, an injected treatment for more severe eczema. To be marketed as Dupixent, it is a first-in-class drug for patients who are suffering despite other treatments.
Dupixent, which is also expected to be a blockbuster, is on course for approval in March. However, last month, Leerink analysts told investors there could be a hangup there. They pointed out the drug is to be filled at the same Sanofi plant that had been cited with a Form 483 by the FDA.
The problems at the plant led the agency to issue a complete response letter to Sanofi and Regeneron for sarilumab, a drug that would compete with Humira, and also is expected to generate big sales. The FDA didn’t have any issues with the safety or effectiveness of the drug, but said they wanted the plant issues resolved before they would approve the experimental IL-6 inhibitor sarilumab.
Editor's Note: The story was updated to include a statement from Pfizer.