Milestone Pharmaceuticals announced that the FDA has accepted the company’s NDA for Cardaymyst etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). Milestone originally submitted the NDA in October 2023, and the FDA issued a Refuse to File letter in December 2023. The company re-submitted the NDA in March 2024.
Milestone President and CEO Joseph Oliveto commented, “The FDA’s acceptance of our NDA for Cardamyst brings Milestone one step closer in our mission in providing a new, convenient and effective treatment option for patients with PSVT. We understand the frequent impact that PSVT has on patients, as well as the under-appreciated burden it places on their families and caregivers. Our progress toward providing a sense of security for patients is a result of the dedicated Milestone team, patients, and investigators to whom we are thankful.”
Read the Milestone Pharmaceuticals press release.