Schizophrenia drug wins federal approval

Johnson & Johnson won federal approval Wednesday for a schizophrenia drug derived from another top-selling anti-psychotic medicine.

The Food and Drug Administration said Invega will add to the treatment options for the disabling mental disorder, which affects about 2 million Americans.

It also could add to the bottom line for J&J, which faces the loss of patent protection in December 2007 for the No. 3 anti-psychotic drug, Risperdal. Risperdal, also called risperidone, had $2.3 billion in sales in 2005, according to the pharmaceutical data company IMS Health.

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Confronted with the prospect of competition from generic versions of the drug, the New Brunswick, N.J.-based company seeks a further six months’ patent protection for Risperdal by studying its use in children.

Invega, also called paliperidone, is derived from Risperdal. The body breaks down Risperdal to form paliperidone.

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Unlike Risperdal, Invega will be sold in extended-release tablet form. The company didn’t disclose the drug’s cost, saying only that it would be priced competitively with other anti-psychotics.

Schizophrenia is marked by hallucinations, delusions, disordered thinking and movements and cognitive deficits, the FDA said.