FDA Approves Alkermes’ Schizophrenia Treatment Aristada

Aripiprazole lauroxil

The Food and Drug Administration on Monday approved Alkermes PLC’s schizophrenia treatment clearing the way for the Dublin-based bio pharmaceutical company to start selling the drug.

Aristada, or aripiprazole lauroxil, will be available as a once-monthly and six-week injection, is a generic version of Abilify.

In April, the FDA approved four other generics of Otsuka Pharmaceutical Co.’s best-selling drug Abilify by Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals Industries Ltd. and Torrent Pharmaceuticals Ltd.

In 2014, the last full year in which Bristol-Myers Squibb Co. had exclusive rights to sell Abilify in the U.S., it reported $2.02 billion in sales of the drug. Bristol-Myers’ exclusive rights ended in April along with Otsuka’s Abilify market exclusivity.

Schizophrenia is a chronic, disabling brain disorder that affects about 1% of the U.S. population, according to the National Institute of Mental Health.

Aristada is not approved to treat patients with dementia-related psychosis. The most common adverse reactions in a clinical trial were insomnia, headaches and akathisia, a form of inner restlessness.

Company officials have scheduled a conference call with analysts on Tuesday at 7:30 a.m. ET.

Shares, up 2.1% this year, rose 6% in late trading to $63.50.


Oct. 5, 2015

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