Drugs

Biogen Says Data Show Aduhelm Working Over 2 Years

Biogen says new data show that after 128 weeks of Aduhelm (aducanumab-awwa) treatment, patients in the long-term extension phase of Phase 3 trials “continued to experience reductions in two key Alzheimer’s disease pathologies….” A company statement said the data were “meaningful findings, which further our understanding of amyloid and downstream biomarkers … in Alzheimer’s disease and can help inform how long patients may benefit from treatment to reduce amyloid beta plaque. These data demonstrate that long-term treatment with Aduhelm continues to reduce the underlying pathologies of Alzheimer’s disease beyond two years.”

A second company statement said peer-reviewed Phase 3 EMERGE and ENGAGE trial data were published in The Journal of Prevention of Alzheimer’s Disease. Company officials said the publication will help doctors better understand the appropriate use of Aduhelm. It includes results from the primary, secondary, and tertiary endpoints in the trials, as well as safety data and biomarker sub-studies.

The FDA 6/7/21 accelerated approval of Aduhelm ignited a firestorm of criticism that led to the resignation of several advisory committee members. In the aftermath, then-acting commissioner Janet Woodcock said the process could have been better handled and called for an HHS Office of Inspector General review.

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