Cytokinetics received a green signal from the FDA for its cardiac myosin inhibitor, which has reserved the biotech to compete with Bristol Myers Squibb in the heart disease sector. This approval cased adult group of aficamten with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This is an inherited condition that leads to thickening of the heart muscles. Individuals suffering from oHCM show symptoms like shortness of breath. The new approved product Myqorzo is a commercialisation name for Cytokinetics.
The approval was granted after merging the molecule with the noteworthy improved exercise potential in patients fighting these diseases. For the analysts who crossed their fingers for the win of Cytokinetics, the major center of discussion was the detailed overview of the Risk Evaluation and Mitigation Strategy (REMS). The FDA took three months to release the review, three months from May, as it wanted to take ample time to review the biotech’s REMS proposal.
The promising data from the MAPLE-HCM study ramped at the European Society of Cardiology Congress in September. The data highlighted that after 24 weeks of treatment, the aficamten patients witnessed a 1.1-mL/kg/min increase in pVO2, a calculation of oxygen supply that designates exercise potential. The equivalent of the standard of care beta-blocker, metoprolol, experienced a 1.2 mL/kg/min decrease in pVO2 within a similar timeframe.
Stifel analysts in a note to investors said, “The approved REMS is aligned with their expectations and is classified and well compared with BMS’s Camzyos. Cytokinetics’ REMS provides a certain level of flexibility to physicians, allowing them to titrate quickly within two weeks and conduct an echocardiogram evaluation in eight weeks after dose completion and any accompanying dose change. The dosing can be titrated after a fixed announcement of no delay.”
Cytokinetics chief commercial officer, Andrew Callos, on a call with analysts, told them to discuss the approval that patients dosing of 10 or 15 mg Myqorzo can meet their focused dose quickly in four to six weeks. Following, Stifel analysts wrote down the most flexible measured requirements while maintaining the potential to down-titrate without disturbing the treatment.
Alongside, it also listed the absence of drug-to-drug interaction monitoring as a favorable aspect of the REMS requirements. Analysts said, “Moreover, the aficamten needs fewer cheers with a predictable and flexible clinical profile that enables the physicians to maintain the health of the patients as they see fit.”
Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.
