MyoKardia's Mavacamten Receives the US FDA's Breakthrough Therapy Designation for Symptomatic Patients with Obstructive Hypertrophic Cardiomyopathy
Shots:
- The US FDA has granted BTD to mavacamten for the treatment of symptomatic- obstructive hypertrophic cardiomyopathy (HCM)
- In May’2021- MyoKardia reported the results of the P-III EXPLORER study that demonstrated the robust treatment effect- with patient responses to treatment- including reductions in symptoms- improvements in cardiac function and reduction or elimination of the obstruction of the left ventricle and was well tolerated
- MyoKardia is currently preparing an NDA for mavacamten- with plans to submit to the FDA in Q1’21
Ref: GlobeNewswire | Image: MyoKardia
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