The U.S. Food and Drug Administration has approved WINREVAIR (sotatercept-csrk) for the treatment of pulmonary arterial hypertension (PAH).

 

Phase 3 BALANCE Study in Fabry Disease

 

PAH is a rare disorder affecting the heart and lungs. It is characterized by abnormally high blood pressure (hypertension) in the pulmonary artery. Symptoms are usually progressive and may include shortness of breath during exercise, fainting spells, dizziness, swelling of the ankles or legs, chest pain, and a racing pulse. Some cases of PAH are due to genetic changes in the BMPR2 gene but others may have no identifiable cause. PAH can also occur secondary to underlying conditions or be induced by certain drugs and toxins.

Sotatercept-csrk is an activin signaling inhibitor therapy, the first to be approved by the FDA for PAH. The therapy targets the regulation of vascular cell proliferation that underlies PAH. This approval comes from the results from the phase 3 STELLAR clinical trial where sotatercept achieved its primary endpoint of change from baseline in six minute walk distance.

For more information on PAH and other rare pulmonary disorders, visit https://checkrare.com/diseases/lung-diseases/