The primary endpoint is the change from baseline in the 6-minute walk test (6-MWT) at 12 months. Secondary endpoints will evaluate the efficacy of patisiran on quality of life using the Kansas City Cardiomyopathy Questionnaire Overall Summary, and composite endpoints of mortality and hospitalization.
“ATTR amyloidosis is a rare, debilitating, and life-threatening disease encompassing hereditary ATTR (hATTR) amyloidosis and wild-type ATTR (wtATTR) amyloidosis. Based on the encouraging exploratory results on cardiac endpoints in the Phase 3 APOLLO study, we are investigating the potential for patisiran to treat cardiovascular-related manifestations of ATTR amyloidosis,” said Eric Green, Senior Vice President and General Manager, TTR Program. “The initiation of APOLLO-B represents a significant milestone in our commitment to explore the full potential of patisiran for patients living with all types of ATTR amyloidosis.”
Patisiran is the non-branded drug name for ONPATTRO. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of the polyneuropathy of hATTR amyloidosis in adults. ONPATTRO is also approved in the European Union, Canada, and Japan.
Source: Company Press Release