Drugs

2 New Nucala Administration Options Approved

FDA has approved two new methods for administering GlaxoSmithKline’s Nucala (mepolizumab) — an autoinjector and a pre-filled safety syringe — for patients with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis. This is the first anti-IL5 biologic to be licensed in the U.S. for at-home administration, and the first respiratory biologic to be approved for administration with an autoinjector, Glaxo says. The company’s original lyophilized powder version remains available for administration by a healthcare professional.

The approval was supported by patient experience data from two open-label, single-arm, Phase 3 studies (NCT03099096 & NCT03021304) evaluating the real-world use of Nucala administered via the new options in-clinic and at home by patients with SEA, or by their caregivers. “Both studies showed patients were able to successfully self-administer treatment with both the autoinjector and pre-filled syringe after appropriate training (89-95% and 100% respectively),” the company says. “In addition, the majority of patients preferred at home self-administration options compared to in-clinic administration.”

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