FDA Approves Sotatercept-csrk for Pulmonary Arterial Hypertension

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Sotatercept-csrk is the first approved activin signaling inhibitor therapy for pulmonary arterial hypertension, which represents a new class of therapy.

The FDA has approved sotatercept-csrk (Winrevair; Merck and Co Inc) for the treatment of adults with pulmonary arterial hypertension (PAH), according to a press release from the company. Sotatercept-csrk is approved as an injection in the 45 mg and 60 mg dosage to increase exercise capacity, improve World Health Organization Group 1 functional class, and reduce the risk of clinical worsening events.1

A detailed view of the complex network of blood vessels in a biological sample | Image Credit: Nilima - stock.adobe.com

Image Credit: Nilima - stock.adobe.com

Sotatercept-csrk is the first approved activin signaling inhibitor therapy for PAH, which represents a new class of therapy intended to improve the balance of pro- and anti-proliferative signaling regulating vascular cell proliferation, according to the press release.1

“[PAH] is a rare, progressive and ultimately life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart,” Marc Humbert, MD, PhD, professor of medicine and director of the Pulmonary Hypertension Reference Center at the Université Paris-Saclay, said in the press release. “Based on the Phase 3 STELLAR trial, adding [sotatercept-csrk] to background PAH therapy demonstrated significant clinical benefits compared to background PAH therapy alone. This approval is an important milestone, as it offers health care providers a novel therapeutic option that targets a new PAH treatment pathway.”1

The approval is based on the STELLAR (NCT04576988) phase 3 trial comparing sotatercept-csrk with the placebo in combination with background standard of care therapies in adults with PAH.1

About The STELLAR Trial

Trial Name: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)

ClinicalTrials.gov ID: NCT04576988

Sponsor: Acceleron Pharma Inc, a wholly-owned subsidiary of Merck & Co Inc

Completion Date: December 2022

In the study, 163 individuals received sotatercept-csrk and 160 received the placebo. Individuals were previously receiving stable background therapy and received either the placebo or the study drug every 3 weeks, according to the study authors. The primary endpoint was change from baseline at week 24 in 6-minute walking distance. The secondary endpoints included multicomponent improvement, change in pulmonary vascular resistance, change in N-terminal pro-B-type natriuretic peptide level, improvement in WHO functional class, time to death or clinical worsening, French risk score, and changed in Pulmonary Arterial Hypertension-Symptoms and Impact Physical Impacts (PAH-SYMPACT), Cardiopulmonary Symptoms, and Cognitive/Emotional Impacts domain scores.2

The results demonstrated that sotatercept-csrk and background therapy increased the 6-minute walking distance from baseline by 41 meters at week 24, according to the press release. Further, the combination therapy significantly improved multiple important secondary outcome measures, which included reducing the risk of death from any cause and clinical worsening events by approximately 84% when compared to background therapy alone.1

The first 8 secondary endpoints were significantly improved, except for PAH-SYMPACT Cognitive/Emotional Impact Domain scores, according to the study authors. Adverse events included epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure.2

“New treatment options continue to be needed for patients with [PAH] that support important clinical goals, including increasing exercise capacity and improving functional class,” Aaron Waxman, executive director of the Center for Pulmonary Heart Diseases at Brigham and Women’s Hospital, said in the press release. “Sotatercept added to background therapy has the potential to become a new standard of care option for patients with [PAH].”1

The drug should be given ever 3 weeks by subcutaneous injections and may be administered by an appropriate patient or caregiver with guidance after training and follow-up from a health care provider, according to the press release. Previously, sotatercept-csrk was previously granted breakthrough designation.1

References
  1. FDA Approves Merck’s Winrevair (sotatercept-csrk), a First-in-Class Treatment for Adults with Pulmonary Arterial Hypertension (PAH, WHO Group 1). News release. Merck. March 26, 2024. Accessed March 27, 2024. https://www.merck.com/news/fda-approves-mercks-winrevair-sotatercept-csrk-a-first-in-class-treatment-for-adults-with-pulmonary-arterial-hypertension-pah-who-group-1/
  2. Hoeper MM, Badesch DB, Ghofrani HA, et al. Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2023;388(16):1478-1490. doi:10.1056/NEJMoa2213558
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