Drugs

Study Questions Some Accelerated Approval Uses

A cross-sectional study by researchers at Yale University and other institutions raises questions about the use of the FDA accelerated approval program for certain therapeutic agents, especially if post-approval trials neither consistently evaluate clinical outcomes nor are much longer than pivotal trials using surrogate endpoints. As reported in a JAMA Network open access article, the amount of time FDA grants sponsors of accelerated approval drugs to conduct post-approval confirmatory clinical benefit studies has come under increased scrutiny since the agency gave Biogen nine years for the confirmation trial for its Alzheimer’s drug Aduhelm (aducanumab).

“Better understanding whether post-approval trial durations, which are generally expected to measure clinical outcomes and be longer than pivotal trials focused on surrogate markers, justify the study timelines set by FDA is critical because these drugs can remain on the market for an extended period without confirmatory evidence,” the researchers write.

The study concludes that the findings suggest that prolonged results-reporting deadlines may not be justified given the marginal differences in pivotal and post-approval trial durations of therapeutic indicators recently receiving FDA accelerated approval.

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

Read more

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