FDA Approves Alkermes' Schizophrenia Treatment Aristada
October 05 2015 - 9:06PM
Dow Jones News
By Maria Armental
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.
Write to Maria Armental at maria.armental@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
October 05, 2015 20:51 ET (00:51 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
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