Drugs

GSK Reports Trial Results of Nucala in COPD

GSK says “headline” results from its Phase 3 MATINEE clinical trial evaluating chronic obstructive pulmonary disease drug (COPD) Nucala (mepolizumab) met its primary endpoint — “statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo with patients treated for up to 104 weeks.” The monoclonal antibody, which targets interleukin-5 (IL-5) in adults with COPD, is intended as an add-on therapy to inhaled maintenance therapy, the company says, adding that the trial’s safety results are consistent with the known safety profile of Nucala.

Further data analysis of the data is ongoing, GSK notes. “The full results of MATINEE will be presented at a future scientific congress and will inform ongoing discussions with regulatory authorities,” it says.

Nucala was first approved in 2015 for severe asthma with an eosinophilic phenotype. The company says it is under development for treating a range of IL-5-mediated diseases associated with Type 2 inflammation.

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