Cutia Therapeutics (HKG: 2487), a developer of dermatology therapies, has announced that its CU-10201, a 4% minocycline foam agent for external use, has received market approval from the National Medical Products Administration (NMPA) in China. The approval is for the treatment of non-nodular moderate to severe acne vulgaris in individuals aged 9 and above, an indication that was awarded priority review status in August.
CU-10201: A Pediatric Dosage Form for Acne Treatment
CU-10201 is recognized as the world’s first and only external minocycline formulation to treat acne and is the first of its kind to be approved in China with priority review status. This new pediatric dosage form offers several advantages over other major anti-acne antibiotics and traditional oral drugs, including lower systemic drug exposure, fewer side effects, lower drug resistance, and potentially higher patient compliance.
Efficacy and Safety Data
The NMPA approval is based on the efficacy and safety data from a Phase III clinical study conducted in China. The study demonstrated CU-10201’s significant therapeutic effect on acne and good safety profile, with a reduction in the common side effects associated with oral minocycline.-Fineline Info & Tech
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