FDA accepts NDA for Journey Medical’s DFD-29

The US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for DFD-29 (minocycline hydrochloride modified release capsules, 40mg) for the treatment of inflammatory lesions and erythema of rosacea in adults.

The drug is under development by US dermatology specialist Journey Medical Corporation (Nasdaq: DERM), whose shares rose more than 7% to $3.65. The noted that the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of November 4, 2024.

“We are pleased that the FDA has set a PDUFA date of November 4, 2024, for DFD-29 and we look forward to collaborating with the agency throughout the review process in order to bring this unique treatment option to patients suffering from rosacea,” said Claude Maraoui, co-founder, president and chief executive of Journey Medical: “If approved, we believe that DFD-29 will be the only oral medication to address both inflammatory lesions and erythema (redness) from rosacea, and will be a preferred treatment option by physicians and their patients to address the condition,” he explained.