US FDA approves Bayer's Finacea

The US Food and Drug Administration has approved German pharma major Bayer’s (BAYN: DE) Finacea (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Finacea Foam will be available by prescription-only beginning in September 2015, the company noted.

The approval is based on results from two pivotal clinical trials examining the efficacy and safety of Finacea Foam compared to its foam vehicle (without the drug azelaic acid) in the topical treatment of papulopustular rosacea. Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.

In two pivotal clinical trials, treatment with Finacea Foam resulted in a higher Investigator's Global Assessment (IGA) success rate compared to vehicle control (32.1% versus 23.4% in trial 1 and 43.4% vs 32.5% in trial 2), as well as a greater reduction in the mean nominal change of inflammatory lesion count from baseline to the end of the 12-week treatment period (-13.2 vs -10.3 in trial 1 and -13.3 vs -9.5 in trial 2). The most frequently observed adverse reactions in ≥ 0.5% of subjects treated with Finacea Foam included local application site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%).