BMS Reports the US FDA’s Acceptance of NDA for Mavacamten to Treat Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

 BMS Reports the US FDA’s Acceptance of NDA for Mavacamten to Treat Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

BMS Reports the US FDA’s Acceptance of NDA for Mavacamten to Treat Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots:

  • The NDA submission is based on results from the P-III EXPLORER-HCM trial involves assessing Mavacamten vs PBO in 251 patients with symptomatic oHCM. The FDA has anticipated a PDUFA date of January 28, 2022
  • The P-III EXPLORER-HCM trial results demonstrated the robust treatment effect, with patient responses to treatment, including reductions in symptoms, functional status, QoL and reduction or elimination of the obstruction of the left ventricle. The study met 1EPs and 2EPs with statistical significance
  • Mavacamten is an oral, allosteric modulator of cardiac myosin for patients with symptomatic oHCM and is currently not approved for use in any country

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Fierce Biotech

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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