Merck: Winrevair approved in US

(CercleFinance.com) - Merck & Co announces that the US FDA has approved its Winrevair to treat pulmonary arterial hypertension in adults, to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening.


This approval is based on the SLARLAR Phase 3 trial, which showed that the product, in combination with background therapy, significantly improved exercise capacity and multiple important secondary measures compared to background therapy alone.

Winrevair is administered once every three weeks by subcutaneous injection. Merck estimates that the drug will be available for dispensing in selected specialty pharmacies in the US by the end of April.


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