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Merck’s sotatercept approval brings vascular remodeling to PAH

ARTICLE | Regulation

Approval marks the start of a new disease-modifying treatment paradigm for the rare disease and related indications

By Lauren Martz, Executive Director, Biopharma Intelligence

March 26, 2024 11:38 PM UTC

Updated on Mar 27, 2024 at 10:08 PM UTC

Editor’s note: This article has been updated to reflect the therapy’s price and its method of delivery

With the approval of first-in-class Winrevair sotatercept from Merck, pulmonary arterial hypertension patients gain a therapeutic mechanism that targets the underlying disease pathology — abnormal signaling in the pulmonary artery walls — marking the start of a disease-modifying treatment paradigm for PAH and related indications.

Winrevair, which Merck & Co. Inc. (NYSE:MRK) gained through its $11.5 billion acquisition of Acceleron Pharma Inc. in 2021, was approved to treat PAH, a population that Merck told BioCentury represents about 40,000 patients in the U.S. …