Galderma gets FDA blessing for Aklief

Galderma has received the Food and Drug Administration’s green light for Aklief (trifarotene) cream, in a dosage strength of 0.005%, for the topical treatment of acne.

Trifarotene is the first new retinoid molecule to receive FDA approval for the treatment of acne in more than 20 years, the company said.

“The approval of Aklief cream underscores our ability to bring new active molecules to the community, and innovate even in well-established therapeutic classes. It is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated, including acne,” said Thibaud Portal, Galderma global vice president, prescription. “We are pleased to add this new treatment option, with proven efficacy in facial and truncal acne, to our innovative and differentiated portfolio of acne treatments.”

Aklief cream is expected to be available in the United States in November 2019. It will be provided in a 45 gram pump.