The approval was based on data from 5 randomized, double-blind, placebo-controlled trials that included 317 patients with supraventricular tachycardia.
Participants were randomly assigned to receive subcutaneous sotatercept or placebo every 21 days with background PAH therapy. The primary endpoint was the time to first confirmed morbidity or ...
Imkeldi is a liquid formulation of imatinib that utilizes proprietary technology to allow for accurate dosing and an alternative formulation to tablets.