(Reuters) -Journey Medical said on Monday the U.S. Food and Drug Administration has approved its drug for the treatment of a long-term skin condition called rosacea, sending the company’s shares up nearly 12% before the bell.
The oral drug, branded Emrosi, was approved to treat inflammatory lesions associated with the disease, which mostly affects women and men in the age group of 30 to 60 years.
Rosacea is a chronic inflammatory skin condition that causes persistent redness and small pus-filled bumps, typically affecting the central face area.
The condition affects more than 16 million Americans, according to the American Academy of Dermatology.
Doxycycline capsules, branded as Oracea and owned by Galderma, is the current standard-of-care treatment for inflammatory lesions from rosacea in adult patients.
Emrosi will be commercially available to U.S. patients late in the first quarter or early in the second quarter of 2025, Journey said.
The company did not immediately respond to a Reuters request for details on the drug’s pricing.
The drug, also known as DFD-29, is a low-dose minocycline, an antibiotic used for skin infections.
Journey had sought approval of DFD-29 for the treatment of both inflammation and redness or erythema associated with rosacea.
The FDA’s decision was based on two late-stage clinical trials where the drug met the main goal after 16 weeks of treatment with no significant safety issues.
The drug showed a reduction in the total inflammatory lesion count and facial redness in both studies when tested against Oracea and placebo.
B. Riley Securities analyst Kalpit Patel estimates Emrosi to capture at least 50% of Oracea’s market share and generate sales of at least $150 million at peak.
(Reporting by Sruthi Narasimha Chari, Puyaan Singh and Mariam Sunny in Bengaluru; Editing by Alan Barona and Shilpi Majumdar)
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