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news.Johnson & Johnson has received a 'not approvable' letter from the FDA for the company's application to use its antipsychotic Risperdal in the treatment of autism.
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A supplemental new drug application (sNDA) for Risperdal (risperidone) was submitted to the FDA by Johnson & Johnson Pharmaceutical R&D (J&JPRD), a member of the Johnson & Johnson family of companies, in the hope of further expanding the product’s label.
J&JPRD said that it is evaluating the FDA’s letter and will determine the appropriate next steps for Risperdal in this indication.
Risperdal, which is indicated for the treatment of schizophrenia and for bipolar mania, is the most frequently prescribed antipsychotic medication in the US. The drug has received some bad press of late after a trial found that elderly patients with dementia-related psychosis treated with Risperdal were at an increased risk of death compared to placebo.
In the trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group, according to a safety update on the drug’s official website.