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US regulator clears Merck’s lung therapy after ‘significant’ results

The US regulator, the Food and Drug Administration, has approved Winrevair therapy of Merck & Co., Inc., to treat pulmonary arterial hypertension.

 HQ Team

March 27, 2024: The US regulator, the Food and Drug Administration, has approved Winrevair therapy of Merck & Co., Inc., to treat pulmonary arterial hypertension.

The FDA nod for sotatercept-csrk, branded as Winrevair, came after a late-stage trial showed “significant improvement” in exercise capacity and other secondary outcome measures compared to background therapy alone.

Twenty-nine percent of the adult patients in the first three phases of the disease who were treated with Winrevair had an improvement in WHO functional class compared to 14% of patients treated with placebo. 

The World Health Organization functional class describes how severe a patient’s pulmonary hypertension symptoms are. There are four different classes – I is the mildest and IV is the most severe form of pulmonary hypertension.

Risk of death

For trial participants suffering from pulmonary arterial hypertension, the therapy reduced the risk of death or clinical worsening events by 84% compared to the placebo, according to a Merck statement.

Treatment with Winrevair also led to an improvement in pulmonary vascular resistance.

Merck’s therapy is the first activin signalling inhibitor therapy approved by the FDA to treat the disease, according to the statement. The company has a licensing agreement with Bristol Myers Squibb for the therapy.

The injection works by improving the balance between pro- and anti-proliferative signalling to regulate vascular cell proliferation underlying the disease.

The therapy was previously granted Breakthrough Therapy Designation by the FDA. The designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on clinically significant endpoints.

Blood vessels thicken

“Pulmonary arterial hypertension 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,” said Dr Marc Humbert, Professor of Medicine and Director of the Pulmonary Hypertension Reference Center at the Université Paris-Saclay.

Based on the trial, adding Winrevair to background therapy demonstrated “significant clinical benefits” compared to background therapy alone,” he said.

Pulmonary arterial hypertension is a rare, progressive disorder characterised by high blood pressure in the arteries of the lungs for no apparent reason, according to the National Organisation for Rare Disorders.

No cure

The pulmonary arteries are the blood vessels that carry blood from the right side of the heart through the lungs. Symptoms include shortness of breath, especially during exercise, chest pain, and fainting episodes. The exact cause of is unknown and although treatable, there is no known cure for the disease.

“New treatment options continue to be needed for patients with pulmonary arterial hypertension that support important clinical goals, including increasing exercise capacity and improving functional class,” said Dr Aaron Waxman, Executive Director of the Center for Pulmonary Heart Diseases at Brigham and Women’s Hospital and investigator of the study.

“Sotatercept added to background therapy has the potential to become a new standard of care option for patients with pulmonary arterial hypertension.”


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