FDA approves Merck lung disease drug acquired in $11B deal

The Food and Drug Administration on Tuesday approved a new Merck & Co. drug to treat pulmonary arterial hypertension. Called Winrevair, the drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to death within a decade of diagnosis.

The FDA’s approval was based on clinical trial data showing Winrevair improved exercise duration and quality of life, as well as delayed death or worsening of the disease.

The shot, known scientifically as sotatercept, blocks proteins that contribute to the thickening of blood vessel walls in the lung and lead to rising blood pressure, an overworked heart and symptoms like shortness of breath, fatigue and chest pain. It’s administered every three weeks.

“Sotatercept is a paradigm shift and a huge step forward in the treatment of PAH,” said Ioana Preston, a study investigator and director of the pulmonary hypertension center at Tufts…
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