Sarepta to submit rolling NDA for eteplirsen to treat DMD
After completing the meeting with the agency, the company has agreed to initiate a rolling NDA submission and will submit the non-clinical and CMC components of the NDA
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have granted paediatric clinical trial waivers to Shanton Pharma for its lead candidate SAP-001, easing the drug’s regulatory paths to approval.
Namzaric is a once-daily, fixed-dose combination of memantine hydrochloride extended-release (a NMDA receptor antagonist), and donepezil hydrochloride (an acetylcholinesterase inhibitor). Last December, the US Food and Drug Administration