Drugs

FDA Gives Thumbs Up to Eisai Phase 3 Alzheimer’s Study

FDA has given Eisai the green light to move its early Alzheimer’s disease drug E2609 into Phase 3 clinical studies. During a recent end-of-Phase 2 meeting, the agency confirmed there were sufficient data to support the advancement of the novel investigational oral beta-secretase cleaving enzyme (BACE) inhibitor, according to the company. E2609 was discovered by Eisai and is being jointly developed with Biogen.

During the meeting, FDA gave input on two Phase 3 clinical study protocol designs. “The study protocol will be a placebo-controlled design in patients with early Alzheimer’s disease where the treatment group will be administered a dosage of 50 mg/day of E2609 with the primary outcome endpoint assessed at 24 months.” Eisai says. The primary endpoint will be the Clinical Dementia Rating Sum of Boxes, with routine safety assessments, it says.

The Phase 2 study evaluated E2609 in patients with early to moderate Alzheimer’s disease (including prodromal Alzheimer’s) with confirmed accumulation of amyloid beta by positron emission tomography screening. Results suggested favorable safety at all doses, and that total amyloid beta levels were reduced in a dose-dependent manner, Eisai says.

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