FDA Approves Alkermes’ Schizophrenia Treatment Aristada

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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October 6, 2015 / Pharma News