Drugs

Actelion Files sNDA for Opsumit

Actelion Pharmaceuticals has filed a supplemental NDA to expand the indication for Opsumit (macitentan) to include treating adults with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) to improve exercise capacity and pulmonary vascular resistance (PVR). The submission is based on data from the MERIT-1 trial, which showed significant improvements in the primary and secondary endpoint of PVR and six-minute walk distance, respectively, compared with background therapy.

“A substantial proportion (almost 40%) of CTEPH patients are deemed inoperable and current pharmacological treatment options for these patients are limited to one therapy only,” the company says. “MERIT-1 provides the first randomized controlled trial data involving patients on combination therapy, addressing a key unmet need in CTEPH.”

Opsumit is an orally active endothelin receptor antagonist that is currently approved for treating pulmonary arterial hypertension to delay disease progression and hospitalization.

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