JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

New efficacy data reported for pivotal Study 213 shows significant, clinically meaningful improvements in agitation symptoms.

Agitation symptoms negatively impact functioning, disease progression, quality of life and care for about half of Alzheimer’s dementia patients – and are a consistent predictor of nursing home admission.

REXULTI® is the first drug approved by the FDA for agitation associated with dementia due to Alzheimer’s disease.

November 06, 2023 - PRINCETON, N.J. & DEERFIELD, Ill.--(BUSINESS WIRE)--Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Lundbeck Pharmaceuticals LLC (Lundbeck) announce that treatment with REXULTI® (brexpiprazole) resulted in statistically significant and clinically meaningful improvements in adult patients with agitation associated with dementia due to Alzheimer’s disease, according to the complete results of the placebo-controlled pivotal phase 3 Study 213 (NCT03548584), published today in JAMA Neurology.1 In May 2023, brexpiprazole became the first and only drug to receive approval from the Food and Drug Administration for this indication. REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.

Study 213 is the second pivotal phase 3 study, in addition to Study 283 (NCT01862640), to report positive efficacy and good tolerability for brexpiprazole, compared to a placebo, when used to treat patients with agitation associated with dementia due to Alzheimer’s disease.2 The JAMA Neurology publication is the first to report the efficacy of brexpiprazole to significantly improve each of three classifications of agitation symptoms: aggressive behaviors, physically nonaggressive behavior and verbally agitated behavior... Otsuka and Lundbeck's Press Release -  TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03548584

 

Lundbeck : European commercialization rights for Flurizan® from Myriad, USA - a new drug in final phase III development for the treatment of Alzheimer

22-05-2008 - H. Lundbeck A/S and Myriad Genetics, Inc. announced that Lundbeck has acquired European commercialization rights to Myriad's Flurizan® (tarenflurbil). Flurizan® might have the potential to delay disability in patients suffering from Alzheimer's disease.
Myriad and Lundbeck have entered into a European commercialization agreement under which Lundbeck will have rights to market and sell Flurizan® in the European Union and several associated non-EU countries and will manage the regulatory process.

Lundbeck has agreed to pay Myriad an initial USD 100 million and will pay up to USD 250 million in connection with regulatory approvals. Furthermore, Lundbeck has agreed to pay attractive commercialization milestones and will purchase bulk pharmaceutical material from Myriad.
Lundbeck has also agreed to pay escalating royalties of 20 - 39% on sales less the amount paid for the bulk drug... Lundbeck's Press Release -