FDA Approves Journey Medical's Emrosi for Rosacea Lesions

The US Food and Drug Administration (FDA) has given the green light to Journey Medical’s Emrosi (minocycline hydrochloride extended release capsules 40mg) for the treatment of inflammatory lesions in adults with rosacea. Rosacea is a chronic inflammatory skin condition that affects over 16 million individuals in the US, characterized by pronounced facial redness, acne-like lesions, and visible facial blood vessels.

The FDA's approval of Emrosi stems from the successful outcomes of two 16-week phase 3 clinical trials conducted by Journey Medical in collaboration with Dr Reddy’s Laboratories. These trials met all their primary and secondary goals without any significant safety concerns. Emrosi demonstrated clear superiority over the existing standard treatment, Galderma’s Oracea 40mg capsules, and placebo, particularly in achieving success in the Investigator’s Global Assessment for treatment as well as in reducing the total count of inflammatory lesions.

Rosacea not only manifests physically but also has profound psychological effects. Surveys by the National Rosacea Society reveal that 90% of patients report diminished self-confidence and self-esteem due to the condition. Additionally, 41% avoid social interactions or cancel events, while 88% with severe symptoms acknowledge negative impacts on their professional lives, and 51% have missed work because of rosacea.

Claude Maraoui, co-founder, president, and CEO of Journey Medical, emphasized the challenges of treating rosacea and expressed optimism about Emrosi’s potential to become a leading oral treatment based on the favorable phase 3 trial results. He highlighted that the company’s experienced dermatology-focused sales team is gearing up for a successful product launch, aiming to establish Emrosi as the new benchmark in rosacea treatment.

Srinivas Sidgiddi, vice president of research and development at Journey Medical, also noted the significant efficacy and tolerability of Emrosi observed in clinical trials. He expressed gratitude to all participants and contributors to this achievement. Journey Medical expects the initial supply of Emrosi to be available by late in the first quarter or early in the second quarter of 2025.