FDA Approves Merck’s WINREVAIR™ (sotatercept-csrk), a First-in …
Mar 26, 2024 · WINREVAIR is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH.
The U.S. FDA has approved WINREVAIRTM (sotatercept-csrk) for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is a novel therapeutic option that targets a new PAH treatment pathway.
Drug Trials Snapshots: WINREVAIR | FDA
Jul 1, 2024 · The FDA approved WINREVAIR based on evidence of safety and effectiveness from a clinical trial of 323 patients with PAH (WHO group 1 functional class II or III).
Winrevair: FDA approves new drug that may help stop PAH | CNN
Mar 26, 2024 · Winrevair was approved by the FDA on Tuesday to help treat pulmonary arterial hypertension. Winrevair is a biologic drug designed to grab onto and trap proteins called activins that are...
WINREVAIR is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional...
FDA approves sotatercept, now Winrevair, to treat PAH in adults
Mar 27, 2024 · The U.S. Food and Drug Administration (FDA) has approved the under-the-skin injection therapy sotatercept-csrk — to be marketed under the brand name Winrevair — to treat adults with pulmonary arterial hypertension (PAH).
Winrevair (sotatercept) FDA Approval History - Drugs.com
Apr 2, 2024 · FDA approval of Winrevair was based on the placebo-controlled Phase 3 STELLAR trial. The primary efficacy endpoint was the change from baseline at Week 24 in 6-Minute Walk Distance (6MWD).
FDA approves Winrevair for pulmonary arterial hypertension in …
Mar 29, 2024 · The U.S. Food and Drug Administration has approved Winrevair (sotatercept-csrk) as an injectable treatment for pulmonary arterial hypertension (PAH) in adults.
FDA Approves Winrevair for Pulmonary Arterial Hypertension in …
THURSDAY, March 28, 2024 -- The U.S. Food and Drug Administration has approved Winrevair (sotatercept-csrk) as an injectable treatment for pulmonary arterial hypertension (PAH) in adults. The FDA previously granted Winrevair a breakthrough therapy designation.
On March 26, 2024, Merck announced the FDA approval of Winrevair (sotatercept-csrk), 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 of clinical worsening events.