PTC Therapeutics received a Complete Response Letter from the Food and Drug Administration (FDA) for Ataluren’s New Drug Application (NDA). This means that the FDA has completed its review of the drug application and has decided it will not approve the drug.
We are deeply disappointed about the FDA’s decision about Ataluren. We look forward to hearing more communication from PTC Therapeutics. If you have any questions for PTC please send them to Alicia@CureDuchenne.org and they will be forwarded to the company.
We appreciate PTC’s commitment to the Duchenne community.
CureDuchenne will continue to fund research until there is a cure for all individuals living with Duchenne. CureDuchenne will not give up!