Bristol Myers Squibb submission for Mavacamten to treat Obstructive Hypertrophic Cardiomyopathy accepted by USFDA
Princeton: Pharma major, Bristol Myers Squibb, has recently announced that the U.S. Food and Drug Administration (USFDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, oral, allosteric modulator of cardiac myosin, for patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 28, 2022.
"HCM, which is the most common inherited heart disease, can be a chronic, debilitating, and progressive condition where patients may experience symptoms of shortness of breath, dizziness and fatigue as well as serious, life-altering complications, including heart failure, arrhythmias, stroke and sudden cardiac death," said Roland Chen, M.D., Senior Vice President, Cardiovascular Development, Bristol Myers Squibb.
Mavacamten is a first-in-class, oral, allosteric modulator of cardiac myosin, under investigation for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Mavacamten is thought to work by reducing cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation that results in hypercontractility, left ventricular hypertrophy and reduced compliance. In clinical and preclinical studies, mavacamten has consistently reduced biomarkers of cardiac wall stress, lessened excessive cardiac contractility, and increased diastolic compliance.
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