Otsuka, Lundbeck head into key FDA panel meeting with agency support for their Rexulti application

Seeking a new approval to curb agitation in Alzheimer's patients, Lundbeck and Otsuka Pharmaceutical are gearing up for an important test Friday. And it appears the FDA is open to a potential nod for their atypical antipsychotic Rexulti.

In briefing documents ahead of a joint meeting of two FDA advisory committees, FDA reviewers noted that in two phase 3 studies, Lundbeck and Otsuka's Rexulti was shown to reduce agitation over a 12-week period. The drug is already approved for schizophrenia and major depressive disorder, and its safety profile was similar in this new proposed use, the FDA said.

The FDA's Psychopharmacologic Drugs Advisory Committee and its Peripheral and Central Nervous System Drugs Advisory Committee are set to discuss the application on Friday and vote on whether there is a patient population that might benefit from the therapy.

Agitation is "one of the most common and challenging aspects" of caring for patients with Alzheimer's disease, the FDA staffers said in their document. There are no FDA-approved treatments for this specific manifestation of the disease.

While doctors have come up with ways to treat agitation, such as off-label use of antipsychotics, antiepileptics and opioids, the FDA also noted various risks associated with those approaches.

Enter Rexulti. In their application, Lundbeck and Otsuka "demonstrated a statistically significant treatment effect" with two different dosing regimens across two phase 3 trials. A third trial failed to reach its primary endpoint but did show a "nominally significant" effect compared with placebo, the FDA said.

"In summary, the applicant appears to have provided substantial evidence of effectiveness (via two adequate and well-controlled trials meeting their prespecified primary endpoint) for brexpiprazole for the treatment" of agitation from Alzheimer's, the reviewers said.

Up next, the FDA's independent advisers will have their say. The group will meet all day Friday to discuss the data, the disease and potential use of the drug to treat agitation from Alzheimer's.

A potential approval for the drug in this use could boost Rexulti's peak sales by $500 million, SVB Securities analysts said in a June 2022 note. Last year, Lundbeck reported 2.85 billion Danish kroner ($405 million) in sales from the drug.

After seeing the new documents, the SVB team said that it supports a positive vote from the advisory committees.