WINREVAIR® (sotatercept) is now authorized for use in Canada for Adults with Pulmonary Arterial Hypertension
KIRKLAND, QC, September 4, 2024 – 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 www.merck.ca and connect with us on LinkedIn and X @MerckCanada.
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