The U.S. Food and Drug Administration approved Attruby (acoramidis) for adults with cardiomyopathy of wild-type or variant (hereditary) transthyretin-mediated amyloidosis (ATTR-CM) “to reduce death and hospitalization related to heart problems”; it is “taken orally, twice daily,” with “recommended dosing…available in the prescribing information.”
In a multicenter, international, randomized, double-blind, placebo-controlled study of 611 adults with wild-type or hereditary (variant) ATTR-CM, the primary endpoint included “all-cause mortality and cumulative frequency of cardiovascular-related hospitalizations” over 30 months; at 30 months, “more patients taking Attruby vs placebo were alive (81% vs 74%)” and there were “fewer” cardiovascular-related hospitalizations (mean 0.3 vs 0.6 per year).
- The most common adverse reactions reported were “diarrhea and upper abdominal pain”; these gastrointestinal adverse reactions were “categorized as mild and resolved without drug discontinuation.”
ATTR-CM: Acoramidis approved to reduce mortality and CV hospitalizations
Source
verahealth
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