Drugs

GSK’s Nucala Approved for Certain COPD Patients

FDA has approved GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype and remain inadequately controlled on current therapies. This marks the first biologic approved for this specific group of COPD patients, the company says.

Approval was based on data from two Phase 3 clinical trials, MATINEE and METREX, in which mepolizumab significantly reduced the annual rate of moderate and severe COPD exacerbations compared to placebo, according to GSK. These flare-ups, which can result in hospitalizations and increased mortality, remain a major challenge in COPD management, it says, adding that mepolizumab targets patients with elevated levels of eosinophils — a type of white blood cell associated with inflammation.

GSK says the trials showed mepolizumab reduced the annual rate of moderate or severe exacerbations by about 18–21% compared to placebo. In the MATINEE trial, it also showed a reduction in exacerbations leading to emergency department visits or hospitalizations, though this result was not statistically significant, it says.

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