Sotatercept

KIRKLAND, QC , Sept. 4, 2024 /CNW/ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada , announced that WINREVAIR ® (sotatercept) is now authorized for use in Canada in combination with standard pulmonary arterial hypertension (PAH) therapy, for the treatment of adults with World Health Organization [WHO] Group 1 PAH and Functional Class (FC) II or III. Sotatercept is the first activin signaling inhibitor therapy for PAH in Canada . This represents a new class of therapy that works by improving the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation in PAH patients. “We understand the burden that PAH places on patients and caregivers. The approval of WINREVAIR ® represents a step forward for those grappling with this disease. Our commitment to advancing scientific research and developing solutions stands firm to address the unmet needs of Canadians,” said David D. Jones , Managing Director of Merck Canada. About STELLAR The STELLAR study (NCT04576988) was a global, double-blind, placebo-controlled, multicenter, parallel-group clinical trial in which 323 patients with PAH (WHO Group 1 FC II or III) were randomized 1:1 to sotatercept (target dose 0.7 mg/kg) (n=163) or placebo (n=160) plus stable background therapy administered subcutaneously once every 3 weeks. The most common PAH etiologies were idiopathic PAH (59%), heritable PAH (18%), and PAH associated with connective tissue diseases (CTD) (15%). Most participants were receiving either three (61%) or two (35%) background drugs for PAH, and 40% were receiving prostacyclin infusions. The mean time from PAH diagnosis was 8.8 years. Patients had a WHO FC II (49%) or III (51%) at baseline. WINREVAIR ® is the subject of a licensing agreement with Bristol Myers Squibb. About Merck At Merck, known as MSD outside of the United States and Canada , we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable, and healthy future for all people and communities. For more information about our operations in Canada , visit and connect with us on LinkedIn and X @MerckCanada. Forward-Looking Statement of Merck & Co. 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The recommendation was based on data from the initial interim analysis of the Phase III KEYNOTE-A39 clinical trial. Credit: R Photography Background/Shutterstock. Merck & Co has received European Commission (EC) approval for the use of Keytruda (pembrolizumab) along with Padcev (enfortumab vedotin-ejfv) as a first-line treatment for adults with unresectable or metastatic urothelial carcinoma, a type of bladder cancer. The authorisation follows the European Society for Medical Oncology and the European Association of Urology’s endorsement of this combination therapy as the preferred initial treatment for these patients, regardless of their eligibility for platinum-based chemotherapy. The EC’s decision is in line with the positive recommendation from the Committee for Medicinal Products for Human Use received in July 2024. The recommendation was based on the data from the initial interim analysis of the Phase III KEYNOTE-A39 clinical trial, conducted in collaboration with Pfizer and Astellas. The open-label, multicentre, randomised, active-controlled study compared KEYTRUDA plus enfortumab vedotin to platinum-based chemotherapy. See Also: FDA approves Amneal and Shilpa’s oncology product BORUZU A quick guide to transferring a commercial drug product to a new fill-finish CDMO The combination showed statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS). At a median follow-up of 17.3 months, the combination therapy reduced the risk of death by 53% and disease progression or death by 55% versus platinum-based chemotherapy. The approval enables the marketing of KEYTRUDA in combination with enfortumab vedotin for this indication across all 27 European Union member states, along with Liechtenstein, Iceland, Norway and Northern Ireland. In December 2023, the combination therapy received approval in the US to treat locally advanced or metastatic urothelial cancer in adults. Merck’s research laboratories oncology, global clinical development head and senior vice-president Dr Marjorie Green stated: “For the first time in decades, adult patients with unresectable or metastatic urothelial carcinoma have the option of a potential new first-line standard of care that may help extend their lives. “We are pleased with the European Commission’s decision, and we look forward to being able to provide KEYTRUDA as part of this novel treatment regimen for this devastating disease to patients in the European Union.” The development comes after the EC approved MSD’s Winrevair (sotatercept) to be used as a combination therapy for functional class II or III pulmonary arterial hypertension. This content was updated on 25 January 2024