US: Convicted Felons Bristol-Myers want approval for ABILIFY (antipsychotic) for children

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Posted by the Asbury Park Press on 06/5/07

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Bristol-Myers Squibb Co., which has about 7,700 workers in New Jersey, asked U.S. regulators for permission to sell its antipsychotic drug Abilify to treat schizophrenia in adolescents.

The U.S. Food and Drug Administration will consider whether the pill, cleared for adult use in 2002, can safely treat patients ages 13 to 17, the company said today in a statement. The FDA typically reviews pediatric medicines within six months.

No drugs are approved in the U.S. to treat schizophrenia in teens, although doctors often prescribe them to patients in that age group. Eli Lilly & Co. and Johnson & Johnson have also asked the FDA to clear drugs for use in teenagers. Sales of Abilify surged 41 percent last year, the biggest increase among antipsychotics, helped by studies showing it caused less weight gain than competing drugs.

"I would expect Abilify to gain the most prescriptions from an approval for adolescent use because younger patients appear to be more susceptible to weight gain than adults,'' said Jeffrey Lieberman, chairman of psychiatry at Columbia University in New York.

Drugmakers sold more than $15 billion in antipsychotic medicines last year, according to data compiled by Bloomberg.

About 15 percent of sales came from doctors writing so-called off-label prescriptions for unapproved uses such as treatment of teens, analysts say.

"There's no gold standard for treating schizophrenia in teens, and the first company to get FDA approval for this will have an edge in this very crowded market,'' said Les Funtleyder, an analyst at Miller Tabak & Co. in New York, in a telephone interview.

The shares of Bristol-Myers, based in New York, fell 18 cents to $30.26 at 9:49 a.m. in New York Stock Exchange composite trading. The stock has climbed 16 percent this year.

Johnson & Johnson, of New Brunswick, said the FDA may decide as early as
this month whether its antipsychotic Risperdal can be used for schizophrenia and bipolar disorder in adolescents. FDA action on Indianapolis-based Lilly's antipsychotic Zyprexa was slowed in April, when the agency requested more time to review that pill for the same two conditions.

Abilify had sales of $1.3 billion last year. Sales of Zyprexa grew 3.8 percent to $4.4 billion last year. J&J's Risperdal generated $4.2 billion, an 18 percent increase.

Use of the newer antipsychotics in younger patients has risen sharply in recent years, prompting concern among doctors and parents because the drugs aren't approved for children and can cause weight gain and diabetes.

Post a Comment   View All Comments Lilly is shopping for more bodies. They tried giving the drug to seniors with dementia, off-label (against the law). They have been urging doctors to give it to children off-label (against the law). Now they are trying to "go legal" and give it to adolescents- not for schizophrenia. Adolescents don't get schizophrenia. But they will urge it for every possible use under the sun. The company; most companies, expecially with psychiatric drugs, go for the most vulnerable groups. First, people who are mentally ill. Zyprexa is approved for brief use for bipolar mania: My son was given it for TWO years until he died of it from profound hyperglycemia. Second, old people (all those dead people who had dementia). And now, what we have been expecting, children. Many children take it and the other antipsychotics already, and many are dead or have suffered permanent metabolic harm. Do not use this drug. It kills. Posted by: elliel on Tue Jun 05, 2007 11:18 am Zyprexa promotion Eli Lilly makes billions on diabetes treatment and also gets $4.2 billion a year in sales of their biggest cash cow Zyprexa which has been scandalized as *causing* diabetes as a major side effect. In 2004, the American Diabetes Association found that Zyprexa was more likely to cause diabetes than many other antipsychotic drugs. Zyprexa off label promotion scandal is all over the news now. Lilly drug reps are alleged to have called their marketing ploy,"Viva zyprexa". Zyprexa which is only FDA approved for schizophrenia (.5-1% of pop) and some bipolar (2% pop) and then an even smaller percentage of theses two groups. There are now 8 states (and counting) going after Lilly for fraud and restitution. -- Daniel Haszard http://www.zyprexa-victims.com Posted by: DannyHaszard on Tue Jun 05, 2007 11:13 am Post a Comment   View All Comments