Eli Lilly and Co.'s best-selling schizophrenia drug Zyprexa is poised to get U.S. approval for treating adolescents diagnosed with mental illness after a senior government regulator overruled his colleagues.
A three-member Food and Drug Administration team initially urged rejecting the drug for pediatric use because of inconsistent data from studies in U.S. and Russian teens. In an April 29 memo posted on the FDA's Web site, Thomas Laughren, head of the agency's psychiatry division, said the drug's benefits in some studies outweighed the reviewers' concerns.
Zyprexa, with $4.4 billion in global sales in 2006, is Lilly's biggest revenue producer and the best-seller among five drugs known as atypical antipsychotics.
The drug's market leadership has slipped because of surging pediatric prescriptions for competing products and side effects linked to Zyprexa. Johnson & Johnson's Risperdal last month became the only drug in the class cleared for pediatric use though doctors long have prescribed the pills to children, according to market research.
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