FDA Approves Alkermes's Schizophrenia Drug

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Oct. 6 — The FDA Oct. 5 approved Aristada (aripiprazole lauroxil) extended-release injection to treat adults with schizophrenia.

Aristada is administered by a health-care professional every four to six weeks using an injection in the arm or buttocks, the Food and Drug Administration said. The product is manufactured by Dublin, Ireland-based Alkermes Plc.

"Long-acting medications to treat schizophrenia can improve the lives of patients,"" Mitchell Mathis, director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, said. "Having a variety of treatment options and dosage forms available for patients with mental illness is important so that a treatment plan can be tailored to meet the patient's needs."

Alkermes said in a press release that it is preparing to launch Aristada immediately.

Boxed Warning

Aristada and other atypical antipsychotic drugs used to treat schizophrenia have a boxed warning alerting health-care professionals about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis, agency said. No drug in this class is approved to treat patients with dementia-related psychosis.

Aristada must be dispensed with a patient medication guide that describes important information about the drug's uses and risks, the FDA said.

The most common side effect reported by participants receiving Aristada in clinical trials was feeling the urge to move constantly (akathisia), the agency said.

Rejecting Competitor's Petition

On Oct. 5, the FDA denied a July 13 citizen petition submitted on behalf of Otsuka Pharmaceutical Development Commercialization Inc. and Ostuka Pharmaceuticals Co. asking the agency to refuse to approve or delay approval of Aristada.

Aripiprazole is the active ingredient in Otsuka's drug Abilify. The agency said in its response that the ingredient in Aristada is structurally different from the ingredient in Abilify.

Otsuka said in its petition that the FDA should delay or withhold final approval of the 505(b)(2) application for Aristada until Otsuka's three-year exclusivity for aripiprazole expires on Dec. 5, 2017. The 505(b)(2) process is an abbreviated pathway that allows the FDA to rely on data not developed by the applicant for approval of a new drug application.

The petition also asked the agency to refuse to approve the Aristada 505(b)(2) NDA because it doesn't satisfy the substantial evidence of effectiveness requirement because it is only supported with one adequate and well-controlled clinical trial.

In its denial, the FDA said the approval of Aristada can't be blocked by the three-year exclusivity applicable to Abilify because Aristada contains a different active moiety than Abilify.

Also, the FDA said "Alkermes conducted a single adequate and well-controlled clinical trial and bridged to the findings of safety and effectiveness for Abilify (aripiprazole) Tablets (NDA 021436) to support approval of its 505(b)(2) NDA for Aristada" and the agency "has determined that Alkermes has provided substantial evidence that Aristada is effective under the conditions of use prescribed, recommended, or suggested in the drug's labeling."

The FDA's response to Otsuka was addressed to Otsuka's Princeton, N.J., office and to the law firm of Venable LLP.

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