By Denny Jacob
Milestone Pharmaceuticals received a refusal to file letter from the Food and Drug Administration over its new drug application for its etripamil nasal spray to treat a type of abnormal heart rhythm.
The biopharmaceutical company said the FDA determined that the application for etripamil nasal spray as a treatment of paroxysmal supraventricular tachycardia wasn't sufficiently complete to permit a substantive review based on a preliminary review.
The regulator requested clarification about the time of data recorded for adverse events in Phase 3 clinical trials, said Milestone.
Milestone said the FDA didn't express concerns about the nature or severity of adverse events. It will seek clarification and is planning a meeting with the FDA.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
12-26-23 0742ET