Ascendis Pharma Seeks EU Approval for TransCon CNP to Treat Achondroplasia in Children
Ascendis Pharma (ASND) has submitted a marketing authorisation application to the European Medicines Agency for TransCon CNP (navepegritide) to treat children with achondroplasia. The U.S. Food and Drug Administration (FDA) is currently conducting a priority review of the same drug for the same indication, with a decision expected by Nov. 30.
The application submitted to the EMA is supported by data from three clinical trials and up to three years of additional open-label extension data. The drug, TransCon CNP, is designed to increase the production of a protein that promotes bone growth in children. The FDA's priority review status indicates that the agency considers the application to be of significant importance, potentially leading to a faster approval process.
Ascendis Pharma's submission to the EMA and the FDA's priority review of TransCon CNP for treating achondroplasia in children marks a significant step forward in the drug's development. If approved, TransCon CNP could offer a new treatment option for children with this bone growth disorder.
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