J&J's Risperdal Gets New Uses

The Food and Drug Administration on Wednesday approved Johnson & Johnson's(JNJ) Risperdal as the first treatment for schizophrenia in adolescents and for certain psychiatric conditions in children and adolescents.

"The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose and safety of using this product in the pediatric population," said Dr. Dianne Murphy, director of the FDA's Office of Pediatric Therapeutics.

Risperdal may now be used to treat patients ages 13 to 17 for schizophrenia and for patients ages 10 to 17 with bipolar disorder, also known as manic-depressive illness. The FDA permits lithium to be used for bipolar disorder in patients 12 years and older.

The FDA cleared Risperdal in 1993 for treating schizophrenic adults. It was later approved for adults with bipolar disorder, as well as for autism-linked irritability in patients ages 5 to 16.

Both Eli Lilly(LLY) and Bristol-Myers Squibb (BMY) are seeking FDA pproval to expand their schizophrenia drugs -- Zyprexa and Abilify -- to younger patients.

The FDA's decision doesn't affect Risperdal Consta, an injectable version developed in collaboration with Alkermes(ALKS). Risperdal Consta is administered once every two weeks. Risperdal is taken daily.

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