预约演示

Otsuka, Lundbeck eye Alzheimer's indication in FDA adcomm for Rexulti label expansion

2023-03-30

交易

上市批准优先审批临床结果申请上市

Otsuka and Lundbeck’s brexpiprazole is getting a joint FDA adcomm to potentially expand the mental health drug’s label for the treatment of agitation associated with Alzheimer’s dementia. The April 14 meeting includes the Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee. Brexpiprazole is marketed as Rexulti for its approved indications in schizophrenia in adults and children ages 13 and older, as well as for major depressive disorder in adults who are taking other antidepressant medications. Brexpiprazole was discovered by Otsuka Pharmaceutical and is being co-developed by Otsuka and Lundbeck. The FDA approved it in 2015 for the two indications in schizophrenia and depression. The companies first announced that the FDA had accepted the sNDA for brexpiprazole and filed it under priority review in January with a PDUFA target date of May 10. It could be the first pharmacological treatment for agitation in patients with Alzheimer’s dementia in the US, according to a joint press release. The FDA accepted the filing with two Phase III studies which the companies called positive, but they did not spell out the data. One study gave patients 2 mg per day of the drug and showed it was “statistically superior” to the placebo for the primary endpoint of mean change in the Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline to week 12, generating a p < 0.05. The CMAI is a questionnaire with 29 questions to measure the type and frequency of agitated behaviors in elderly nursing home residents, or in this case, patients with Alzheimer’s dementia. In the second study included with the sNDA filing, treatment with 2 and 3 mg of brexpiprazol per day showed “statistically significant improvement” compared with a placebo for the primary efficacy endpoint, the mean change in the CMAI total score from baseline to week 12 (p < 0.05). Agitation is one of the neuropsychiatric symptoms of Alzheimer’s dementia and can display as pacing, gesturing, profanity, shouting, shoving and hitting. It is reported in approximately 45% of patients with Alzheimer’s dementia. Otsuka and Lundbeck are not the only ones moving toward a potential finish line for Alzheimer’s disease agitation. The FDA told Axsome Therapeutics in February that it wanted more safety data from the biotech’s third Phase III study for its candidate for agitation before the company could apply for a label expansion. The agency wants data on at least 300 patients treated for six months and 100 patients on the drug for one year. Axsome’s drug is marketed as Auvelity for treating major depressive disorder.

机构

Otsuka Co., Ltd.