Health & Bio1 min read
Health & Bio
Cytokinetics' Heart Drug Aficamten Hits Goals in Trial for Rare Cardiomyopathy
Biotech company Cytokinetics says its drug aficamten met both main goals of a pivotal trial in non-obstructive hypertrophic cardiomyopathy, improving patients' symptoms and exercise capacity, and plans to seek FDA…
Cytokinetics said its drug aficamten met both primary goals of a pivotal clinical trial in patients with non-obstructive hypertrophic cardiomyopathy, or nHCM, an inherited heart condition, improving how patients felt and their capacity for exercise. The biotech company released the full trial data on a Friday.
It took Cytokinetics 27 years to win its first regulatory approval. The company said a second approval, for aficamten in nHCM, could come much faster. Cytokinetics plans to submit the drug to the United States Food and Drug Administration for approval by the end of the year. If approved, aficamten would be the first treatment specifically cleared for nHCM.
Some experts have described the trial's benefits as limited, though the company is proceeding with its plan to submit the drug for approval based on the full results.
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#Cytokinetics#cardiomyopathy#clinical trial#heart disease
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