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FDA Approves New Treatment for Pulmonary Arterial Hypertension
Merck, known as MSD outside the United States and Canada, has received approval from the U.S. Food and Drug Administration (FDA) for a new treatment for pulmonary arterial hypertension (PAH). The drug, known as WINREVAIRTM, is designed to help adults with PAH increase exercise capacity, improve functional class, and reduce the risk of clinically worsening events.
PAH is a rare and serious condition where the blood vessels in the lungs become thickened and narrowed, putting strain on the heart. According to Dr. Marc Humbert, a professor of medicine, this approval marks an important milestone in offering healthcare providers a new therapeutic option for tackling PAH.
The approval comes after successful results from the Phase 3 STELLAR trial, which compared WINREVAIR to placebo in combination with standard PAH therapies. The trial showed that adding WINREVAIR to background therapy significantly increased the distance walked in six minutes and reduced the risk of death or PAH worsening events by 84%.
However, healthcare providers need to monitor certain blood parameters, including haemoglobin and platelet levels, before each dose of WINREVAIR and periodically thereafter. This is because WINREVAIR may lead to increases in haemoglobin and decreases in platelet count, which could potentially cause complications.
The Pulmonary Hypertension Association has welcomed the approval of WINREVAIR, recognising the importance of new therapies for PAH patients. PAH can be life-changing due to its chronic and progressive nature, causing symptoms like shortness of breath and fatigue.
Dr. Aaron Waxman, an Executive Director at Brigham and Women’s Hospital, emphasised the need for new treatment options that address important clinical goals for PAH patients, such as increasing exercise capacity and improving the functional class. He believes that WINREVAIR has the potential to become a new standard of care for PAH.
WINREVAIR is administered once every three weeks via subcutaneous injection and may be given by patients or caregivers under the guidance of a healthcare provider. Merck estimates that the drug will be available for dispensing by select pharmacies in the U.S. by the end of April.
Dr. Eliav Barr, senior vice president at Merck Research Laboratories, expressed pride in bringing this novel medicine to patients affected by rare diseases like PAH. Merck also offers support to patients prescribed WINREVAIR, including assistance with insurance coverage and out-of-pocket costs through the Merck Access Programme.
The approval of WINREVAIR represents a significant advancement in the treatment options available for PAH patients, offering hope for improved quality of life and better management of this challenging condition.
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