FDA approves Galderma's Soolantra Cream for treatment of rosacea lesions

Galderma Laboratories announced that the U.S. Food and Drug Administration has approved Soolantra Cream for once-daily, topical treatment of inflammatory rosacea lesions, according to a press release.

“Rosacea is a common and challenging condition to manage as it tends to vary from patient to patient, often requiring a tailored approach. For that reason, we are always looking for innovative new treatments,” Linda Stein Gold, MD, a Galderma consultant and clinical investigator for the phase 3 studies of Soolantra Cream (ivermectin cream, 1%), said in the release. “While some rosacea treatments … may take more than 4 weeks to show effect, Soolantra Cream may provide initial results as early as week 2.”

Linda Stein Gold

The FDA action was based on two phase 3, multicenter, 12-week, parallel group studies in which ivermectin met co-primary efficacy endpoints. Treatment effects were observed as early as week 2, with continuous improvement thereafter. Additionally, the treatment demonstrated safety and was well-tolerated during long-term extensions of the studies for an additional 40 weeks, according to the release.

Ivermectin was also shown to be more efficacious when compared in a head-to-head study with metronidazole 0.75% cream – a current gold standard – from 3 weeks onward, according to the release.

Reference: www.galdermausa.com.