Drugs

FDA Misses GSK Nucala for COPD Review Decision

In what looks to be a common occurrence in the wake of recent downsizing and the subsequent departure of its leadership, FDA has now missed a 5/7 user fee review action target date for a GSK supplemental NDA for Nucala (mepolizumab) and its use as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease with an eosinophilic phenotype.

The monoclonal antibody was first approved in 2015 for severe asthma with an eosinophilic phenotype. It is said to work by targeting and binding to interleukin-5, a key messenger protein (cytokine) in Type 2 inflammation. The submission is based on data from the 804-patient MATINEE study, which met its primary endpoint of achieving a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo.

GSK says that based on recent discussions with the agency, it is still expecting an eventual approval for the submission.

Experts have warned that the upheaval at FDA is likely to lead to missed or delayed user fee review actions. Late last month, FDA missed a user fee review action extension on a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for treating Barth syndrome (see story). The review was extended in January to allow FDA to review supplemental information provided in response to recent requests that were received following the agency’s Cardiovascular and Renal Drugs Advisory Committee 10/10/2024 meeting, which voted 10 to 6 for approval.

Also, last month, FDA missed a 4/1 review action target date for Novavax’s Covid-19 vaccine BLA, which the company is seeking to transition from an emergency use authorization to full approval. The agency held up the decision it seeks to conclude a post-marketing commitment from the company (see story).

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