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Review
. 2024 Jul;84(7):857-862.
doi: 10.1007/s40265-024-02058-9. Epub 2024 Jun 21.

Sotatercept: First Approval

Connie Kang  1
Affiliations
Review

Sotatercept: First Approval

Connie Kang. Drugs. 2024 Jul.

Abstract

Sotatercept (sotatercept-csrk; WINREVAIRTM) is an activin signalling inhibitor that is being developed by Merck and Co., Inc. (Rahway, NJ, USA) for the treatment of pulmonary arterial hypertension. Sotatercept recently received approval in the USA for the treatment of adults with pulmonary arterial hypertension [World Health Organisation (WHO) Group 1] to increase exercise capacity, improve WHO functional class and reduce the risk of clinical worsening events. This article summarizes the milestones in the development of sotatercept leading to this first approval for pulmonary arterial hypertension.

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References

    1. Merck Sharp & Dohme LLC. WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use: US prescribing information. 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761363s000lbl.pdf . Accessed 21 May 2024.
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    1. Merck Sharp & Dohme. FDA approves Merck's WINREVAIR(Tm) (sotatercept-csrk), a first-in-class treatment for adults with pulmonary arterial hypertension (PAH, WHO* Group 1) [media release]. 26 Mar 2024. http://www.merck.com .
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