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Merck’s Winrevair Approved For PAH In Europe As Initial US Launch Progresses

Q1 Revenue Totaled $70m, 60% From Stocking

 
• By Mandy Jackson

Merck & Co. won European Commission approval for Winrevair on top of other medicines for pulmonary arterial hypertension and expects an initial EU launch in Germany.

PULMONARY HYPERTENSION Top view, Doctor writing medical records on a clipboard, medical equipment
Winrevair was approved in Europe for use on top of other PAH medicines • Source: Shutterstock

Merck & Co., Inc. has received clearance for Winrevair (sotatercept) from the European Commission (EC) exactly five months after it was approved in the US, where the commercial launch to date has exceeded expectations. The firm is planning to launch Winrevair in European markets later this year, likely starting in Germany.

Key Takeaways

  • The European Commission approved Winrevair (sotatercept) for pulmonary arterial hypertension, five months after it won US FDA approval.

  • Merck will need to negotiate reimbursement in each EU market and expects to launch first in Germany later this year, but has seen strong initial uptake in the US

Merck said on 26 August that the EC approved Winrevair for use in combination with other pulmonary arterial hypertension (PAH) therapies in the treatment of adults with World Health Organization

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