The US Food and Drug Administration has approved the supplemental New Drug Application (NDA) for Bristol-Myers Squibb‘s Abilify for the treatment of irritability associated with autistic disorder in paediatric patients.
The NDA has been approved for patients aged six to 17 years, for symptoms including aggression towards others, causing deliberate self-injuries and quickly changing moods.
The approval of Abilify is based on data from two eight-week, randomised, double-blind, Phase III trials in which the drug significantly improved scores on the irritability subscale of the caregiver-rated Aberrant Behaviour Checklist.
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