Biologics

Alzheimer’s Therapy Gets At-Home Injection Approval

FDA has approved an Eisai/Biogen at-home injection option for Alzheimer’s treatment Leqembi (lecanemab), expanding access to patients in the early stages of the disease. The approval covers Leqembi Iqlik, a once-weekly subcutaneous autoinjector of lecanemab for maintenance dosing.

Patients who have completed the 18-month initiation phase of intravenous (IV) treatment can now either switch to the new autoinjector or continue with monthly IV infusions, the companies say, adding that each injection delivers a 360 mg dose in about 15 seconds.

The FDA decision was supported by sub-studies from the Phase 3 Clarity AD trial. Data showed that switching to the weekly injection maintained the therapy’s clinical and biomarker benefits at levels comparable to continued IV dosing, according to the companies.

More than 600 patients received subcutaneous treatment in clinical testing, including 49 who transitioned to the approved 360 mg weekly regimen. None of those patients experienced injection-related adverse events, they say. Overall, side effects were similar to the IV version but with fewer systemic reactions — less than 1% compared with about 26% for infusions. About 11% experienced mild, temporary local reactions such as redness or swelling at the injection site.

The companies say that rates of amyloid-related imaging abnormalities, a known risk with anti-amyloid drugs, were consistent between the injection and IV formulations.

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