MSD Receives Singapore Health Sciences Authority (HSA) Approval for WINREVAIR® (sotatercept) for the Treatment of Adults with Pulmonary Arterial Hypertension (PAH)
September 23, 2024 2:49 pm Asia/Singapore
WINREVAIR® is the first activin signalling inhibitor therapy for PAH approved in Asia
Singapore is the first country in Asia to receive approval for WINREVAIR®
Singapore, Monday, 23 September 2024 – MSD (trade name of Merck & Co., Inc., Rahway, N.J., USA [NYSE: MRK]) announced today that the Health Sciences Authority (HSA) of Singapore has approved WINREVAIR® (sotatercept), for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1; Functional Class [FC] II to III) to increase exercise capacity, improve WHO functional class, and delay disease progression. This will mark the first availability of this therapy in Asia.
The HSA’s approval of WINREVAIR® is based on safety and efficacy results from the Phase 3 STELLAR trial.
PAH is a rare, progressive and life-threatening blood vessel disorder characterised by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. WINREVAIR®, the first US-FDA-approved activin signalling inhibitor therapy for PAH, works by improving the balance between pro and anti-proliferative signalling to regulate vascular cell proliferation underlying PAH.
“The HSA’s approval of WINREVAIR® provides new hope for PAH patients in Singapore and across Asia,” said Dr Abdullahi Sheriff, Managing Director, MSD in Singapore, Malaysia & Brunei. “This approval is a testament to MSD’s commitment to leading-edge science and driving innovation that can help people affected by cardiovascular and rare diseases like PAH.”
Results from the Phase 3 STELLAR trial show that adding WINREVAIR® to background therapy increased six-minute walk distance from baseline by 41 metres at Week 24, and significantly improved multiple important secondary outcome measures, including 84 per cent reduction in the risk of death from any cause or PAH clinical worsening events compared to background therapy alone. It is administered once every three weeks by subcutaneous injection; it is intended for use under the guidance of a health care professional and may also be administered by patients or caregivers when considered appropriate and when they receive training and follow-up from the doctor.
“The approval of WINREVAIR® in Singapore marks a significant milestone in the treatment of PAH across Asia,” said Dr Ivan Su, Executive Director, Global Medical & Scientific Affairs Lead for Asia Pacific, MSD. “With WINREVAIR®, we are introducing a novel therapy that targets the underlying disease, offering a different approach to care. This is a major step forward in improving both the quality of life and long-term outcomes for patients suffering from this life-threatening condition.”
“Pulmonary Hypertension Singapore (PHSG) welcomes this important development, as we recognise the chronic and progressive nature of PAH and the debilitating symptoms that patients and caregivers live with,” said Mr David Lim, Chairperson of patient group PHSG. “The approval of WINREVAIR® offers the PAH community its first new treatment option in years. We plan to work closely with MSD in Singapore to continue to raise awareness of PAH and to facilitate access to innovative therapies such as WINREVAIR® where appropriate.”
As PAH remains a disease with high morbidity and mortality, the HSA’s approval of WINREVAIR® underscores its dedication to improving patient care and outcomes.
WINREVAIR® will be available for dispensing by select health care providers in Singapore by Q1 2025.
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For more information or media enquiries, please contact:
SPRG
Pooja Shah
Email: pooja.shah@sprg.com.sg
HP: (65) 8889 1321
Cheryl Lum
Email: cheryl.lum@sprg.com.sg
HP: (65) 9389 0638
MSD
Joseph Khong
Email: joseph.khong@msd.com
HP: (65) 9832 0060
About STELLAR
STELLAR (NCT04576988) is a pivotal Phase 3, randomised, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the safety and efficacy of sotatercept compared to placebo, as an add-on to background therapy for the treatment of adults with pulmonary arterial hypertension (WHO Group 1). The primary endpoint is exercise capacity, as measured by 6-minute walk distance (6MWD) 24 weeks following initiation of treatment. Nine secondary outcome measures were assessed: proportion of participants achieving multicomponent improvement (consisting of improvement in 6MWD, improvement in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, and either improvement in WHO FC or maintenance of WHO FC II); change from baseline in pulmonary vascular resistance (PVR); change from baseline in NT-proBNP levels; proportion of participants who improved in WHO FC; time to death or the first occurrence of a clinical worsening event (TTCW); proportion of participants who maintained or achieved a low risk score using the simplified French Risk score calculator; change from baseline in the Physical Impacts domain score of PAH; change from baseline in the Cardiopulmonary Symptoms domain score of PAH-SYMPACT®; and change from baseline in the Cognitive/Emotional Impacts domain score of PAH-SYMPACT®.
Selected Safety Information for WINREVAIR®
WINREVAIR® may increase haemoglobin and lead to erythrocytosis. Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required.
WINREVAIR® may decrease platelet count and lead to severe thrombocytopenia, which may increase the risk of bleeding; thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm 3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required.
In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial haemorrhage) was reported in 4% of patients taking WINREVAIR® and 1% of patients taking placebo. Serious bleeding was more likely in patients on prostacyclin background therapy and/or antithrombotic agents, or with low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR® if the patient is experiencing serious bleeding.
WINREVAIR® may cause foetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a foetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR® and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR® treatment.
Based on findings in animals, WINREVAIR® may impair female and male fertility. Advise patients on the potential effects on fertility.
The most common adverse reactions occurring in the Phase 3 clinical trial (≥10% for WINREVAIR® and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhoea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%).
Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR®, and for 4 months after the final dose.
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation.
Approximately 200 people in Singapore and 15-30 per million people in Asia are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%, based on data from the REVEAL registry (patients enrolled between March 2006 and December 2009).
About MSD
At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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.
We have five diverse divisions and our regional headquarters in Singapore. MSD first set up its sales and marketing (Human Health) office in Singapore in 1993. Established over 30 years ago, MSD has established an extensive footprint here in Singapore and invested in expanding its operations, which include our Asia Pacific headquarters, manufacturing facility, an Animal Health site, a Translational Medicine Research Centre (TMRC), and a Singapore Technology Centre. MSD’s Asia Pacific operations spans 12 markets across the region, with its headquarters in Singapore established since 2007. For more information, visit www.msd.com and http://www.msd-singapore.com; and connect with us on X (formerly Twitter), LinkedIn and YouTube.
Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
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The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information (PI) for WINREVAIR®:
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