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FDA team overuled: Zyprexa 'OK for teen use'

Eli Lilly's schizophrenia drug Zyprexa (olanzapine) may win FDA approval for treating adolescents diagnosed with mental illness after a senior government regulator overruled his colleagues.

Eli Lilly's schizophrenia drug Zyprexa (olanzapine) may win FDA approval for treating adolescents diagnosed with mental illness after a senior government regulator overruled his colleagues.

A three-member FDA team initially rejected the drug for paediatric use because of inconsistent data derived from studies on US and Russian teenagers. In a memo posted on the FDA site on 29 April, Thomas Laughren, who is head of the agency's psychiatry division, said the drug's benefits in some studies outweighed the reviewers' concerns.

Zyprexa racked up USD 4.4bn in global sales in FY06 and as a result is Lilly's biggest earner among the five marketed atypical antipsychotics.

Zyprexa's pole position on the market has degraded somewhat due to safety concerns over the dramatic rises in paediatric prescriptions for competing products and side effects linked to Zyprexa. For example, US-based Johnson & Johnson's Risperdal (risperidone) became the only drug in the class cleared for paediatric use, although doctors have been prescribing the pills off label to children for a long time.

A spokesperson for Lilly said the company performed studies on Zyprexa's use in adolescents not to market the drug to this population, but simply to provide data to prescribers: "If we were to get approval, and that's if, our goal is just to communicate about this in a clinically appropriate manner.

It's not our goal to grow the market in this area or execute a broad promotional campaign."

Industry watchers say they would be very surprised if an eventual FDA approval resulted in an increase in Zyprexa's market share, due to the practice of off-label prescribing. However, some studies have suggested that adolescents who get treatment at the first sign of the disease will have better outcomes. According to Lilly, almost 20 per cent of the first onsets for bipolar disorder occur from 15 to 19 years of age.


28th September 2007

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