Dermatology drugmaker Journey Medical has trekked its Dr. Reddy’s Laboratories-partnered rosacea med across the FDA finish line as Emrosi.
The drug was cleared to treat inflammatory lesions of rosacea in adults after proving its superiority over Galderma’s standard-of-care Oracea capsules, as well as placebo, in two 16-week phase 3 studies measuring reduction in total inflammatory lesion count.
Based on the studies, Emrosi “has potential to become the best-in-class oral medication to treat the condition,” Journey’s co-founder and CEO Claude Maraoui said in a company release, adding, “Our seasoned dermatology-focused sales force is now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea.”
Patients should be able to get their hands on Emrosi in the first quarter or early second quarter of 2025, when Journey expects to finish making the initial U.S. supply, per the release.
Rosacea is estimated to impact more than 16 million U.S. patients and as many as 415 million people worldwide, according to the National Rosacea Society (NRS). The chronic, relapsing inflammatory skin condition is hallmarked by deep facial redness, acne-like lesions and spider veins. More than 90% of patients surveyed by the NRS reported lowered self-esteem due to the condition, with 88% of those with severe symptoms noting that rosacea has affected their professional interactions and 51% having missed work because of the disease.
In addition to Oracea, Journey’s rosacea offering could rival Sol-Gel Technologies’ Galderma-partnered Epsolay, a topical medicine that won approval in 2022. That treatment option uses Sol-Gel’s microencapsulation technology on benzoyl peroxide to control the rate of exposure to the active ingredient with a slow release and mitigate skin irritation.
Emrosi is the latest in Arizona-based Journey’s clutch of skin-focused products, which includes popular severe acne treatment Accutane and Qbrexza, the first prescription towelette used to treat primary axillary hyperhidrosis, or excessive underarm sweating. The latter faces new competition in Botanix’s Sofdra, a topical gel that was approved in June to specifically target underarm sweating as the first and only new chemical entity cleared for the condition, the company said at the time.