Delivery 7–10 daysWinrevair (sotatercept) injection
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Description
💊 Prescription activin signalling inhibitor for pulmonary arterial hypertension in adults — the first drug in this disease aimed at the growth of the vessel wall rather than at its spasm.
▪︎ Sotatercept-csrk, single-dose vial supplied as a kit with a prefilled diluent syringe, vial adapter and alcohol wipes; injected subcutaneously once every three weeks
▪︎ Manufacturer: Merck
▪︎ FDA approval: March 2024
🔬 How it works: in the cells of the pulmonary artery wall two opposing signals meet. One runs through the BMPR2 receptor and restrains cell division; the other, through activins, drives it. In this disease the first is weakened and the second amplified, so the wall thickens and the lumen narrows. Prostacyclins, endothelin receptor antagonists and PDE-5 inhibitors all widen the vessel but leave that thickening untouched. Sotatercept is a receptor fragment fused to an antibody: it traps surplus activins in the blood before they reach the cell. 📊 Evidence: STELLAR (NEJM 2023) in 323 patients on stable therapy — six-minute walk distance 40.8 m better than placebo (p<0.001). ZENITH (NEJM 2025) in 172 high-risk patients — death, lung transplantation or hospitalisation in 17.4% versus 54.7% (hazard ratio 0.24; p<0.001), with hospitalisation for worsening at 9.3% versus 50.0%; the trial was stopped early for efficacy.
⚠️ Prescription-only. Added to background therapy, never a replacement for it. Nosebleeds and telangiectasia are characteristic; haemoglobin rises and platelets can fall, so blood counts are checked before every dose during titration. Effects on fertility are discussed before starting.
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