November 4
Product: Journey Medical’s Emrosi
Indication: Inflammatory lesions of rosacea
Emrosi’s journey to FDA approval is complete after the FDA approved the oral medicine to treat inflammatory lesions of rosacea on Monday.
“Rosacea is a difficult to treat skin condition and based on the favorable results from our Phase 3 clinical trials, Emrosi has potential to become the best-in-class oral medication to treat the condition,” Claude Maraoui, CEO of Arizona-based Journey Medical said in a statement.
Emrosi’s approval is supported by two Phase III trials, in which the treatment met all co-primary and secondary endpoints. Emrosi demonstrated “statistically significant superiority” over the current standard-of-care treatment (Oracea 40-mg capsules) and placebo for Investigator’s Global Assessment treatment success and reduction in total inflammatory lesion count in both trials, Journey Medical reported.
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