UPDATE 1-J&J schizophrenia drug gets wider US approval
(Adds company comment, background)
NEW YORK, April 27 (Reuters) - Johnson & Johnson (JNJ.N) said on Friday that U.S. health regulators have broadened the approval for its Invega antipsychotic drug as a long-term maintenance treatment for schizophrenia.
The drug, a longer-acting version of J&J's Risperdal, was approved in December to treat acute, or short-term, schizophrenia.
The Invega label includes a warning that it could increase the risk of a serious cardiac side effect.
The Food and Drug Administration's latest approval is based on a long-term study that demonstrated a significant benefit in delaying the time to relapse of symptoms of schizophrenia, the company said.
The Invega extended release tablet is taken once daily.
The original approval of the medicine included a warning on the label noting a modest increased risk of QT prolongation, a disorder of the heart's electrical system that can lead to a life-threatening condition.
Pfizer Inc.'s (PFE.N) antipsychotic drug Geodon carries a similar warning.
J&J is hoping to switch Risperdal patients to Invega ahead of the older medicine's patent expiration next year, analysts have said.
Combined global sales of J&J's antipsychotic drugs, including Risperdal and Invega, rose 16 percent to $1.18 billion in the first quarter.
Schizophrenia is a chronic, disabling mental disorder that can cause delusions, hallucinations, social withdrawal and an inability to function.
((Reporting by Bill Berkrot and Ransdell Pierson, editing by Tim Dobbyn; Reuters Messaging: bill.berkrot.reuters.com@reuters.net phone 646 223-6030)) Keywords: JOHNSONANDJOHNSON INVEGA/
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