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BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Camzyos (mavacamten) for Symptomatic Obstructive Hypertrophic Cardiomyopathy

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BMS Receives EMA’s CHMP Positive Opinion Recommending Approval of Camzyos (mavacamten) for Symptomatic Obstructive Hypertrophic Cardiomyopathy

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  • The EMA’s CHMP has recommended approval of Camzyos (cardiac myosin inhibitor) for symptomatic (New York Heart Association, NYHA, class II-III) obstructive HCM
  • The opinion was based on 2 P-III trials (EXPLORER-HCM) & (VALOR-HCM) evaluating Camzyos vs PBO in 251 & 112 adult patients. Both trials met their 1EPs & 2EPs & showed a clear treatment effect in the P-III trial (EXPLORER-HCM) with clinical improvements in exercise capacity, symptoms, and functional status along with an improvement in LVOTO
  • The P-III trial (VALOR-HCM) showed an improvement across cardiac measures who met the 2011 ACC/AHA or 2014 ESC guideline criteria for SRT & were referred for an invasive procedure. The therapy also showed a reduction in need or eligibility for SRT

Ref: Businesswire | Image: Bristol Myers Squibb

Related News:- BMS’ Camzyos (mavacamten) Receives the US FDA’s Approval for the Treatment of Symptomatic New York Heart Association Class II-III Obstructive HCM

Click here to­ read the full press release 

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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.

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