Drugs

Breakthrough Therapy Designation for 2 New Alzheimer’s Drugs

FDA has granted breakthrough therapy designations for drugs from Lilly and Eisai/Biogen intended to treat Alzheimer’s disease. The designation was granted for Lilly’s donanemab, an investigational antibody therapy. The company says the designation is based on clinical evidence in the TRAILBLAZER-ALZ Phase 2 trial that studied the drug’s safety and efficacy in patients with early, symptomatic Alzheimer’s disease.

Lilly says it plans to submit a BLA for accelerated approval of donanemab later this year based on data from the Phase 2 trial.

Eisai and Biogen announced the designation was approved for their lecanemab, an anti-amyloid beta protofibril antibody intended to treat Alzheimer’s. The companies say the designation is based on the recently published results of a Phase 2b clinical study of 856 patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease with confirmed presence of amyloid pathology. They describe lecanemab as an investigational humanized monoclonal antibody that selectively binds to neutralize and eliminate soluble toxic amyloid-beta aggregates that are thought to contribute to the neurodegenerative process in Alzheimer’s disease.

On 6/7, FDA created a controversy with its accelerated approval of Biogen’s Aduhelm (aducanumab-avwa) to treat Alzheimer’s.

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