BMS Receives the US FDA’s Approval of Camzyos (mavacamten) sNDA for Label Update to Treat Symptomatic Obstructive HCM
Shots:
- The US FDA approved an updated label for mavacamten (2.5/5/10/15mg capsules) to reduce the need or eligibility for septal reduction therapy in patients with obstructive HCM, based on (VALOR-HCM) trial
- The P-III study (VALOR-HCM) results from 112 patients showed that ~7% of the randomized patients were NYHA class II, 93% were NYHA class III+, mean LVEF (68%) & mean post-exercise LVOT gradient was 84 mmHg, baseline mean KCCQ-23 CSS was 68 among patients with symptomatic obstructive HCM who met the 2011 ACC/AHA Guideline criteria
- Camzyos met 2EPs i.e., mean post-exercise LVOT gradient (-39 vs -2mmHg), NYHA class improvement of 1 class (63% vs 21%), KCCQ-23 CSS**, mean (+10 vs +2 points), mean change in baseline in KCCQ-23 TSS & PL (+10 vs +2) & (+10 vs +2)
Ref: Businesswire | Image: Bristol Myers Squibb
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
