Drugs

Merck’s Winrevair Sees Phase 2 Pulmonary Hypertension Win

Merck says its drug Winrevair (sotatercept-csrk) significantly improved a key measure of heart–lung function in a mid-stage trial of patients with a rare and hard-to-treat form of pulmonary hypertension linked to heart failure with preserved ejection fraction (HFpEF). Topline data from the Phase 2 CADENCE study showed the drug reduced pulmonary vascular resistance (PVR) at 24 weeks compared with placebo, meeting the trial’s primary endpoint, according to the company. PVR reflects how easily blood flows through the lungs to the heart; elevated levels are associated with worse outcomes in pulmonary hypertension.

The study evaluated sotatercept in adults with combined post- and precapillary pulmonary hypertension (CpcPH) due to HFpEF — a subset of Group 2 pulmonary hypertension caused by left-sided heart disease. CpcPH is associated with worse outcomes and currently has no approved therapies.

CADENCE enrolled 164 patients with NYHA Class II or III symptoms and randomized them to placebo or one of two doses of Winrevair (0.3 mg/kg or 0.7 mg/kg). In addition to PVR, investigators assessed exercise capacity, echocardiographic measures, biomarkers and clinical outcomes. Merck says the safety findings were generally consistent with the drug’s known profile.

Winrevair is currently approved in the U.S. for treating pulmonary arterial hypertension (PAH), where it improves exercise capacity, functional class and reduces the risk of disease progression, hospitalization, and death, Merck says. The drug, developed under a licensing partnership with Bristol Myers Squibb, is the first activin-signaling inhibitor approved for PAH.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome