Milestone Pharmaceuticals says that it held a Type A meeting with the FDA following receipt of a Refuse to File letter in December 2023 in response to the company’s NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). According to Milestone, the agency did not request any additional clinical trials. The company says that it intends to resubmit the NDA in the second quarter of 2024 after making changes to data sets and data files related to timing of adverse events.
Milestone Pharmaceuticals President and CEO Joseph Oliveto commented, “We thank FDA for its thoughtful consideration of our materials and direction on the NDA resubmission. The feedback we continue to receive from key stakeholders, including patients and health care providers, reinforces our belief that etripamil nasal spray has the potential to be a valuable new option for patients with PSVT that may establish a new standard of care, if approved. We are committed to working with FDA to bring this potentially important new treatment to patients and our recent meeting underscores this commitment.”
Read the Milestone Pharmaceuticals press release.
