Milestone Pharmaceuticals says that it completed a Type A meeting with the FDA and subsequently submitted its response to the agency’s complete response letter regarding Milestone’s NDA for Cardamyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). According to the company, the FDA is expected to set a new PDUFA date for review of the application within 30 days.
The company initially submitted the NDA for Cardamyst in October 2023; however, the FDA issued a Refuse to File letter to that application the following month. The NDA was re-submitted in March 2024.
Milestone President and CEO Joe Oliveto commented, “Our recent Type A meeting with the FDA was productive, and we believe it provided the guidance necessary to submit our response to the CRL directly after the meeting. We appreciate the engagement with the FDA and are excited to prepare for a potential new PDUFA date this year. We continue to believe in the value of Cardamyst which, if approved, will be the first and only self-administered therapy for the rapid termination of episodes of PSVT.”
Read the Milestone Pharmaceuticals press release
