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FDA approves Alkermes’ long-acting Abilify

Aristada given the nod as injectable antipsychotic

ireland

Alkermes' Aristada (aripiprazole lauroxil) has been approved by the FDA as a long-acting injectable version of Abilify.

Abilify (aripiprazole) was originally developed by Otsuka Pharmaceuticals, but earlier this year was approved as a generic after a federal judge denied the company further exclusivity for the medication.

Aristada (aripiprazole) is a new treatment option developed by Alkermes, and is, it said “designed to offer flexibility to meet real-world needs of patients” and can be administered with once-monthly and six-week dosing options.

Eliot Ehrich, CMO at Alkermes, said: “Building on nearly two decades of experience developing innovative medicines for chronic and serious CNS diseases, we are dedicated to helping to improve the lives of patients as well as meeting the needs within the treatment ecosystem of caregivers, physicians, payers and society.”

The FDA approval comes on the back of phase III data showing that multiple dose strengths of Aristada met the primary endpoint with statistically significant improvements in schizophrenia symptoms versus placebo.

The study involved 623 patients with schizophrenia with common side effects being headache, insomnia and the urge to move constantly, otherwise known as akathisia. 

The Dublin-based drug manufacturer plans to launch the injection immediately and also plans to explore an additional indication for treatment-resistant depression.

The approval of Aristada will come as further bad news to Otsuka as Abilify generics have also been launched by Alembic Pharmaceuticals, Hetero Labs and TEVA. 

Otsuka's recently approved antipsychotic Rexulti is expected to bring in around $1.4bn but it still has a long way to go to be placed alongside Abilify which last year achieved sales of $5.5bn, 85% of which was generated in the US. 

Article by
Nikhil Patel

7th October 2015

From: Regulatory

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