FDA Approves New Topical Treatment for Actinic Keratosis

01/25/2012

The FDA has approved ingenol mebutate (Picato) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK), Leo Pharmaceuticals announced.

In a series of four Phase III clinical studies of more than 1,000 patients with AKs, Picato gel resulted in a significantly higher number of individuals who saw complete clearance of their AKs. About two thirds of patients (60% to 68 %) with AKs on the face and scalp saw a 75% or greater reduction of existing AKs (versus 7% to 8% with placebo), while 44% to 55% of patients with AKs on the trunk and extremities experienced 75% or more reduction (versus 7% reduction for placebo). Patients treated with Picato gel saw 37% to 47% complete clearance of lesions on the face and scalp, and 28% to 42% on the trunk and extremities, versus up to 5% complete clearance with placebo in all studies.

Local skin responses (LSRs) on the face peaked around day 4 and resolved by day 15 for the majority of patients, Leo Pharmaceuticals reports. LSRs on the trunk and extremities peaked around day 8 and markedly improved by day 29.

According to Leo Pharmaceuticals, Picato Gel is the first and only topical AK therapy that can be used for as little as 2 or 3 days. Picato 0.015% is used once daily on the face and scalp for three consecutive days, and Picato 0.05% is used once daily on the trunk and extremities for 2 consecutive days. According to the American Academy of Dermatology (AAD), nearly a third (65%) of squamous cell carcinoma cases begin as untreated AKs, making a medication like Picato gel, where siginificant resolution of AKs can be achieved, important.

"Since there is no way to predict which actinic keratosis will advance to skin cancer, early detection and treatment of lesions are critical," says study investigator Dr. Mark Lebwohl of the Department of Dermatology at Mount Sinai Medical Center, New York, NY. "What makes this new solution particularly exciting is the two or three day course of treatment."

Local skin responses were the most common adverse event (AE) reported with Picato gel, including erythema, flaking/scaling, crusting and swelling. Fewer than 2% of patients taking Picato gel suffered from worse AEs, including pain, pruritus and infection at the application site as well as periorbital edema and headache.