Milestone Faces Setback as FDA Requests More Data for CARDAMYST Approval

Milestone Pharmaceuticals has hit a temporary roadblock in its journey to bring CARDAMYST™ (etripamil) nasal spray to market. The FDA issued a Complete Response Letter (CRL), highlighting two Chemistry, Manufacturing, and Controls (CMC) issues that must be addressed before approval. The agency’s concerns focus on nitrosamine impurities—based on new draft guidance issued after the NDA submission—and the need for an inspection of a facility that changed ownership during the review process. Notably, the FDA did not raise concerns about the safety or efficacy of CARDAMYST, a promising treatment for paroxysmal supraventricular tachycardia (PSVT).

Despite the setback, Milestone remains committed to gaining approval. CEO Joe Oliveto expressed disappointment but reaffirmed the company’s determination to collaborate with the FDA to resolve the issues. The company plans to request a Type A meeting to discuss the FDA’s feedback and chart a clear path toward resubmission. As the team works to address these concerns, patients and healthcare providers continue to anticipate a new on-demand treatment option for PSVT that could improve the management of acute episodes.