Epiduo Forte Gel is the first combination of retinoid, adapalene and benzoyl peroxide, developed for the moderate to severe acne population.
Acne is the most common skin condition in the US that affects more than 40 to 50 million people.
The approval was based on a pivotal, multicenter, randomized, double-blind, 12-week, vehicle-controlled Phase III trial of Epiduo Forte Gel in which it met each of its primary efficacy endpoints when compared to vehicle gel in 217 acne subjects.
The trial showed superiority of Epiduo Forte Gel over vehicle gel in the overall study population at week 12 for the Investigator’s Global Assessment Success Rate and for changes in inflammatory and non-inflammatory lesion count.
Galderma Laboratories president and general manager Todd Zavodnick said: "As the industry leader in dermatology, Galderma recognizes the need for innovative acne medications across a spectrum of acne severities.
"The FDA approval of Epiduo Forte Gel has helped us expand on our robust acne franchise to deliver a safe, effective and antibiotic-free treatment to patients in need, and underscores Galderma’s continued commitment to skin health and antibiotic stewardship."
The FDA approval of Epiduo Forte Gel further expands the company’s portfolio of dermatologic solutions.
In the Phase III trial, Epiduo Forte Gel was shown to be safe and well tolerated, and most adverse events (AEs) were mild to moderate in severity, which is important for acne patients with sensitive skin.