Drugs

Scientists Ask How FDA Will Review New Alzheimer Drugs

With at least two additional ameloyd-β Alzheimer’s drugs in the pipeline, scientists interviewed for a Nature explainer are wondering how FDA will review and decide on the drugs’ fate given the furor over its accelerated approval of Biogen’s Aduhelm (aducanumab). “Some researchers think that the [Aduhelm] approval will bolster the development of drugs for treating brain disease,” the article says, “but others see it as a blemish on FDA’s integrity and an obstacle to progress.

FDA accelerated its approval of Aduhelm, which is on the market at about $56,000 per year, overruling an agency advisory committee that voted overwhelmingly not to recommend approval.

The article says Lilly expects to finish its application for the antibody donanemab, which works like Aduhelm, in the next few months, leading to an FDA decision in the second half of 2022. And Eisai is working with Biogen to complete the submission of data for lescanemab.

Nature says that following a recent Clinical Trials on Alzheimer’s Disease conference, these are the questions researchers are asking:

whether amyloid-lowering drugs help patients;
when solid data will be available on whether amyloid-β therapies improve cognition;
whether FDA will approve anti-amyloid antibodies;
whether FDA will reconvene at advisory committee for upcoming approvals; and
whether FDA will limit who can be treated with the therapies.

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