Drugs

Axsome Plans Alzheimer’s NDA on Mixed Data

Axsome Therapeutics says it will submit an NDA for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating Alzheimer’s disease agitation despite reporting mixed Phase 3 clinical trial data. The investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor has previously been granted a Breakthrough therapy designation for the indication.

The company says its ACCORD-2 Phase 3 trial achieved the primary endpoint with AXS-05 statistically delaying time to relapse of agitation, which was assessed by the Cohen-Mansfield Agitation Inventory (CMAI) total score. “AXS-05 also met the key secondary endpoint (relapse prevention, p=0.001),” it says. “Further, AXS-05 reduced worsening for overall Alzheimer’s disease severity compared to placebo, as assessed by the Clinical Global Impression of Severity (CGI-S) for Alzheimer’s disease (p<0.001).”

However, Axsome says its ADVANCE-2 Phase 3 trial did not demonstrate statistical significance for the primary endpoint — change in the CMAI total score from baseline to Week 5 (CMAI reductions of 13.8 and 12.6 points for AXS-05 and placebo, respectively). It further says that “results for the primary and nearly all secondary endpoints numerically favored AXS-05 over placebo.”

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