Drugs

1/3 Accelerated Drugs Have Incomplete Confirmatory Trials

More than one-third of accelerated approval drugs (104 of 278 between 1992 and 2021) are past their confirmatory trials’ original planned completion dates, including four that are more than five years past those dates, an HHS Inspector General (IG) data snapshot says. The snapshot is part on an ongoing IG evaluation in the wake of the agency’s recent controversial approval of Biogen’s Aduhelm (aducanumab) for treating Alzheimer’s disease (see earlier story).

The snapshot finds that the 139 applications with completed trials took on average 48 months for FDA to determine that their confirmatory trials were completed. Additionally, it notes that “sponsors may have little incentive to complete trials promptly once they can market a drug under accelerated approval. Likewise, patients may have little incentive to enroll in a confirmatory trial when the therapeutic treatment is already available. Finally, FDA’s process to withdraw a drug approved through the accelerated approval pathway can be lengthy and contentious. These challenges can result in drugs staying on the market—and being administered to patients—for years without the predicted clinical benefit being verified.”

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