Biologics

2nd Alzheimer’s Therapy Death Raises Questions: Journal

Questions are being raised about Eisai and Biogen’s lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody for treating Alzheimer’s disease after a second death was reported in a patient taking the therapy. The journal Science is reporting that a 65-year-old woman who was receiving the promising experimental treatment recently died from a massive brain hemorrhage that some researchers link to the drug. The death, described in an unpublished clinical trial case report Science obtained, is the second thought to be associated with lecanemab. STAT recently reported that a man in his late 80s in lecanemab’s Phase 3 trial died of a brain hemorrhage linked to possible interaction between the antibody and Bristol Myers Squibb’s blood thinner Eliquis (apixaban).

Experts who reviewed the case report of the newly disclosed fatality told Science that it intensifies questions about lecanemab’s safety and how widely it should be prescribed if ultimately approved by FDA and other regulators. Eisai and Biogen have already submitted a BLA for accelerated approval of lecanemab, which FDA accepted in July (see earlier story). The PDUFA action date on the BLA is 1/6/23.

Eisai declined to comment specifically on the deceased woman’s case, according to Science. “All the available safety information indicates that lecanemab therapy is not associated with an increased risk of death overall or from any specific cause,” the company said in a statement. Any safety information is reported to regulators and the trial’s principal investigators, Eisai said. “It can be difficult to determine what contributed to the death in any given patient, in particular when they are elderly, have multiple medical problems and may have recently received a concomitant treatment or intervention for an acute condition,” it added.

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