The U.S. Food and Drug Administration has approved top-selling Abilify as a treatment for autism-related irritability in children from the ages of 6 to 17, drug maker Bristol-Myers Squibb Co. said Friday.
Bristol-Myers and Otsuka Pharmaceutical Co., based in Tokyo, are collaborators on the development and distribution of Abilify in the U.S. and Europe.
Abilify is Bristol-Myers' second-biggest revenue generator, with $2.2 billion in 2008 sales.
The FDA's latest approval allows the drug to be used to treat symptoms associated with autism such as aggression toward others, deliberate infliction of self-injury, tempter tantrums and moodiness.
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The companies said in a statement that it was intended to be used as part of a more comprehensive treatment program that includes educational, psychological and social aspects.
Several other drug companies sell medications that compete with Abilify for customers. One is Schering-Plough Corp.'s Saphris, used to treat schizophrenia and bipolar disorder. Others include Pfizer Inc.'s Geodon, Johnson & Johnson's Risperdal, AstraZeneca PLC's Seroquel and Eli Lilly & Co.'s Zyprexa. The drugs have combined sales of well over $15 billion a year.
Bristol-Myers shares rose 4 cents to $24.50 in after-hours trading Friday after closing at $24.46, up 43 cents from a day earlier.