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
