Zyprexa may get OK for teen use
Senior regulator overrules peers on drug's benefits for adolescents
Star and news service report
September 27, 2007
Rise in diagnoses
U.S. sales of antipsychotics grew 74 percent from 2002 to 2006 to reach $11.5 billion. That was fueled partly by a forty-fold increase in the number of children diagnosed with bipolar disorder over 10 years, according to a study published this month.
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.
Lilly spokeswoman Carole Puls said the company did studies on Zyprexa's use in adolescents not to market the drug to this population but to provide data to physicians.
"If we were to get approval -- and that's if -- our goal is just to communicate about this in a clinically appropriate manner," she said. "It's not our goal to grow the market in this area or execute a broad promotional campaign."
About 20 percent of the first episodes for bipolar disorder occur from ages 15 to 19, Puls said. Few treatments currently are approved for this population.
Many doctors already prescribe medications approved in adults off-label for adolescents, said Kathy Bayes, executive director of NAMI (the National Alliance on Mental Illness) Fort Wayne.
For that reason, Bayes said, she would be "very surprised" if an eventual FDA approval resulted in an increase in Zyprexa's market share.
But, she added, medications can be critical when treating a young person for mental illness. Some studies suggest that adolescents who get treatment at the first sign of the disease will have better outcomes.
And if one of the drugs approved for adults also received the nod for use in adolescents that could have a financial impact, she said.
J&J's Risperdal was cleared Aug. 22 for use by children over 9. Before that, no antipsychotic was approved for kids, though doctors may prescribe drugs to any group for any use once they're on the market. Zyprexa is not approved for pediatric use anywhere else.
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Date d'inscription : 27/09/2007
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