Biologics

Eisai Rolling BLA for Alzheimer’s Drug

Eisai has initiated a rolling BLA submission for lecanemab (BAN2401), the company’s investigational anti-amyloid beta (AB) protofibril antibody for treating early Alzheimer’s disease. The BLA, which is seeking accelerated approval, is based on clinical, biomarker and safety data from the Phase 2b clinical trial (Study 201) in people with early AD and confirmed amyloid pathology. Data from the trial showed a “high degree of AB plaque lowering and consistent reduction of clinical decline across several clinical endpoints,” the company says. “The correlation between the extent of AB plaque reduction and effect on clinical endpoints in Study 201 further supports AB as a surrogate endpoint that is reasonably likely to predict clinical benefit.”

Eisai says it is pursuing accelerated approval after discussing the option with FDA. The sought-after approval pathway mirrors the accelerated approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab-avwa), which relied on the surrogate endpoint of reduction in brain amyloid plaque (see earlier story).

Study 201 showed that at 18 months of treatment, lecanemab significantly reduced brain amyloid, and over 80% of subjects became amyloid negative by a visual read, Eisai says. “Furthermore,” it adds, “the extent of reduction in amyloid was correlated with slower clinical decline on ADCOMS (Alzheimer’s Disease Composite Score), CDR-SB (Clinical Dementia Rating-Sum-of-Boxes), and ADAS-cog (Alzheimer Disease Assessment Scale-Cognitive Subscale) at the treatment group and patient level. The rate of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), an adverse event associated with amyloid targeted therapies, for the 10 mg/kg biweekly dosing was 9.9%.”

A Phase 3 study (Clarity AD) completed enrollment in March with 1,795 patients. The company says FDA has agreed that the results from this study, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab.

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