Incyte (INCY, Financial) recently announced that the U.S. Food and Drug Administration (FDA) has prolonged the evaluation period for their supplemental New Drug Application (sNDA) concerning ruxolitinib cream, branded as Opzelura. This topical Janus kinase inhibitor is aimed at treating children aged 2 to 11 years with mild to moderate atopic dermatitis. The FDA's Prescription Drug User Fee Act (PDUFA) action date has been shifted by three months, now set for September 19, 2025.
The delay allows the FDA to thoroughly assess additional data related to the chemistry, manufacturing, and controls of the 0.75% formulation, as submitted by Incyte following a request for further information. Despite the extension, Incyte maintains confidence in the potential of ruxolitinib cream as a significant non-steroidal treatment option for pediatric patients. The company remains committed to working closely with the FDA to ensure a comprehensive review process.
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