Galderma receives FDA approval for AKLIEF

08 Nov 2019

The Food and Drug Administration (FDA) has approved AKLIEF (trifarotene) Cream 0.005% for the topical treatment of acne.

Pharmaceutical company Galderma stated that trifarotene is the first new retinoid molecule to receive FDA approval for the treatment of acne in more than 20 years. According to Galderma, the AKLIEF Cream is the first topical treatment specifically studied and proven to treat both facial (forehead, cheeks, nose and chin) and truncal (chest, shoulders and back) acne. 

The approval is supported by data from two Phase 3 clinical trials of once-daily AKLIEF Cream in patients with moderate acne on the face and trunk. The two identical 12-week, randomised, multicentre, parallel group, double-blind, vehicle-controlled clinical trials of 2,420 patients showed that AKLIEF Cream significantly reduced inflammatory lesions in as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle. The most common adverse reactions included application site irritation, application site pruritus (itching) and sunburn.


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