FDA Accepts Milestone Pharmaceuticals’ New Drug Application for CARDAMYST Nasal Spray for PSVT’
Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for CARDAMYST
MONTREAL and CHARLOTTE, N.C. May 29, 2024 ’ Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company committed to the innovation, development, and commercialization of unique cardiovascular therapies, proudly announced today that the United States Food and Drug Administration (FDA) accepted the Company’s New Drug Application (NDA) for CARDAMYST (etripamil) nasal spray on May 26, 2024. CARDAMYST is Milestone’s lead investigational product aimed at managing paroxysmal supraventricular tachycardia (PSVT), a condition characterized by episodic rapid heart rates originating above the heart’s ventricles.
The acceptance of the NDA marks a significant milestone in Milestone Pharmaceuticals’ journey to bring a novel treatment option to patients grappling with PSVT. With this step, the FDA has set a Prescription Drug User Fee Act (PDUFA) target date for the review 10 months from the acceptance date, initiating a countdown to potential approval by March 26, 2025.
“We are tremendously pleased with the FDA’s acceptance of our NDA for CARDAMYST,” said Joseph Oliveto, CEO of Milestone Pharmaceuticals. “This regulatory milestone underscores our dedication to developing transformative therapies for patients with cardiovascular diseases. We believe that CARDAMYST, if approved, would provide a significant benefit to the lives of those affected by PSVT, offering a novel and non-invasive treatment option.”
CARDAMYST (etripamil) is designed as a fast-acting nasal spray intended for use in the acute termination of PSVT episodes in patients. PSVT, an unpredictable and sometimes debilitating condition, often necessitates visitations to emergency rooms for management. Therefore, the approval of CARDAMYST is anticipated to offer a convenient and potentially life-changing therapeutic option that can be self-administered at the onset of symptoms.
Milestone Pharmaceuticals remains committed to addressing the unmet medical needs of patients with cardiovascular conditions through pioneering treatments like CARDAMYST. The Company looks forward to collaborating with the FDA throughout the review process and is dedicated to ensuring that CARDAMYST meets the highest standards of safety and efficacy.
As Milestone Pharmaceuticals continues to make strides in cardiovascular medicine, the acceptance of the NDA for CARDAMYST NASAL SPRAY reinforces their position as a leader in the biopharmaceutical industry, driven by a focus on patient-centric innovation.
For more information, visit Milestone Pharmaceuticals’ website and stay updated with future announcements regarding CARDAMYST and other groundbreaking developments.This
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