Milestone Pharmaceuticals announced that it has resubmitted its NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). The FDA had issued a Refuse to File letter in December 2023 in response to the NDA, which the company had submitted in October 2023. In February 2024, Milestone announced that it had held a Type A meeting with the FDA and would make alterations to data sets and data files related to timing of adverse events before resubmitting the NDA.
Milestone President and CEO Joseph Oliveto commented, “We appreciate FDA’s guidance through the resubmission process. We believe we have addressed all the issues raised in the Refusal to File letter and look forward to working with the agency as it reviews our application. If approved, we believe that etripamil nasal spray will be a valuable treatment option for patients suffering from PSVT.”
Read the Milestone Pharmaceuticals press release.
