The US Food and Drug Administration (FDA) has approved sotatercept (Winrevair, Merck), for the treatment of adults with pulmonary arterial hypertension (PAH), World Health Organization (WHO) Group 1, to increase exercise capacity, improve WHO functional class, and reduce the risk for clinical worsening events.
Sotatercept, which had breakthrough therapy designation, is a first-in-class activin signaling inhibitor that works by improving the balance between pro- and antiproliferative signaling to regulate the vascular cell proliferation that underlies PAH.
“Sotatercept added to background therapy has the potential to become a new standard-of-care option for patients with pulmonary arterial hypertension,” added co-investigator Aaron Waxman, MD, PhD, executive director of the Center for Pulmonary Heart Diseases at Brigham and Women’s Hospital, Boston.
The approval was based on results of the phase 3 STELLAR study, a global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial in which, 323 patients with PAH (WHO Group 1, Functional Class II or III) were randomly assigned 1:1 to add sotatercept or placebo to stable background therapy.
The results showed that sotatercept, administered subcutaneously every 3 weeks for 24 weeks, improved average 6-minute walk distance from baseline by a significant and clinically meaningful 40.8 meters compared with placebo for the trial’s primary efficacy endpoint (P <.001 a="" adjustments="" administered="" alone="" also="" american="" an="" and="" any="" april="" are="" at="" available="" average="" background="" baseline="" be="" before="" between="" by="" cardiology="" caregivers="" cause="" clinical="" college="" compared="" count="" death="" decrease="" determine="" difference="" dispensing="" dose="" doses="" dyn="" each="" end="" england="" erythrocytosis="" estimates="" events="" events:="" every="" fc="" federation="" first="" five="" follow-up="" for="" from="" full="" guidance="" hazard="" healthcare="" heart="" hemoglobin="" if="" improvement="" in="" including:="" increase="" information="" initiated="" injection="" is="" joint="" journal="" last="" lead="" led="" levels.="" longer="" may="" measures="" median="" medicine.="" merck="" mg="" monitored="" multiple n-terminal="" natriuretic="" new="" not="" nt-probnp="" of="" online.="" or="" outcome="" p="" pah="" patients="" peptide="" periodically="" pg="" pharmacies="" placebo="" platelet="" platelets="" prescribing="" pro="" provider.="" publication="" pulmonary="" pvr="" ratio="" recommended="" reduction="" reported="" required.="" resistance="" results="" risk="" scientific="" secondary="" select="" sessions="" severe="" should="" significant="" simultaneous="" sotatercept="" specialty="" starting="" states="" target="" that="" the="" therapy="" thereafter="" thrombocytopenia.="" to="" training="" treated="" treatment="" united="" unstable="" values="" vascular="" vs="" was="" weeks="" weeks.="" were="" will="" with="" world="" worsening="" year="">
Source : Medscape