Drugs

Panels to Consider Rexulti sNDA for Alzheimer’s Agitation

A 4/14 joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee will consider a sNDA from Otsuka Pharmaceutical and Lundbeck for their Rexulti (brexpriprazole) to treat agitation in patients with Alzheimer’s dementia. An FDA briefing paper distributed in advance of the meeting says Rexulti was found in two Phase 3 studies to reduce agitation over 12 weeks. The atypical antipsychotic is already indicated to treat schizophrenia and major depressive disorder.

The medical reviewers said agitation is “one of the most common and challenging aspects” of dealing with Alzheimer’s patients and there currently are no FDA-approved drugs for this particular indication.

The reviewers found that Rexulti demonstrated a statistically significant treatment effect with two different dosing regimens across the two Phase 3 trials. A third trial failed to reach its primary endpoint but showed a “nominally significant” effect compared with placebo, the reviewers said.

Members of the panels are asked to discuss:

the overall benefit/risk assessment of Rexulti for treating agitation associated with Alzheimer’s disease;
whether there is a population of patients with Alzheimer’s disease for whom the benefits/risk of Rexulti appear acceptable and a population for whom the benefit/risk does not appear to be favorable; and
whether the companies provided sufficient data to allow the identification of a population in whom the benefits of treating agitation associated with Alzheimer’s disease with Rexulti outweigh the risks.

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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