FDA Approves Milestone Pharmaceuticals' NDA for CARDAMYST™ Therapy
Milestone® Pharmaceuticals, a company focused on cardiovascular treatments, announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray.
The product is intended for the management of paroxysmal supraventricular tachycardia (PSVT), and the FDA has set a Prescription Drug User Fee Act (PDUFA) target date for March 2025, 10 months from the NDA acceptance.
This milestone brings the company closer to providing a new, convenient, and effective treatment option for patients with PSVT. The significance of this progress reflects the commitment of the Milestone team, patients, and investigators involved in the clinical program.
The clinical development of CARDAMYST represents the largest data package ever studied for an acute drug intended for patient self-management of PSVT episodes.
Milestone is advancing preparations for the potential commercial launch of etripamil, which is proposed to be marketed under the brand name CARDAMYST, pending FDA approval.
In the United States, approximately two million people are diagnosed with PSVT, a type of arrhythmia characterized by sudden episodes of rapid heartbeats, often exceeding 150 to 200 beats per minute.
These episodes, which can last for hours, cause severe symptoms such as palpitations, shortness of breath, chest discomfort, and dizziness, significantly affecting patients' daily lives.
The unpredictability of PSVT can lead to anxiety and negatively impact quality of life, particularly for those with underlying cardiovascular conditions. Treatment options are currently limited, often resulting in emergency department visits or invasive procedures like cardiac ablation.
