That’s right. And it’s likely to occur because a senior FDA official overruled his colleagues. A three-member FDA team of medical reviewers initially urged rejecting Zyprexa for pediatric use because of inconsistent data from studies in US and Russian teens, Bloomberg News reports. But in an April 29 memo posted on the FDA’s Web site (look here), Thomas Laughren, head of the agency’s psychiatry division, wrote that 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 seller and the biggest among five antipsychotics. But the teen market is important to Lilly, because Zyprexa’s market share has slipped as 86 percent of psychiatrists are writing fewer scrips due to side effects - weight gain and diabetes. Johnson & Johnson’s Risperdal last month became the only drug in the class cleared for pediatric use though docs have long prescribed the pills to children.

A growing number of states, meanwhile, are suing Lilly over improperly marketing Zyprexa. Their argument - downplaying or hiding side effect data while state Medicaid programs fork over big money for the med.

Lilly’s FDA application to market Zyprexa for pediatric use was based on a six-week study of 107 teenagers with schizophrenia, almost half of them in Russia, and a three-week test of 161 U.S. subjects with bipolar disorder. The FDA reviewers, whose report wasn’t released by the agency, urged Zyprexa’s rejection because the beneficial findings in the schizophrenia trial came mostly from Russia, Laughren wrote. His memo was posted without publicity under a 2002 law requiring the agency to release summaries when it reviews pediatric applications.

As you can see from reading the memo, Laughren acknowledged that the reviewers were concerned that Russian patients had greater responses to the drug and smaller responses to placebos than US patients. They also worried that the relative ease of patient recruitment in Russia was a sign of fraud. An FDA inspection found no such evidence, Laughren insisted. “In summary, while I agree this geographic discrepancy is a concern, I do not think it is, by itself, a sufficient justification for a nonapproval action, when the trial is positive overall on the primary analysis…”

The Russian studies “meet or exceed internationally accepted principles of clinical research,” Lilly’s Puls wrote.

Almost 44 percent of teenagers taking Zyprexa gained more than 7 percent of their body weight, compared with 7 percent of those on placebos, according to Laughren’s memo. But levels of fats, blood sugar and the hormone prolactin increased in patients taking Zyprexa, while dropping in placebo patients.

“A 7 percent increase in body weight in a young patient in such a short time may predispose people to diabetes and create a cardiac burden as the heart is forced to work harder,” Steven Klotz, a child psychiatrist in Harrisburg, Pa., tells Bloomberg. “These medications may help some patients, but I’m worried FDA approval may lead to rampant prescription writing. I don’t want drug reps telling pediatricians every adolescent that throws a tantrum is bipolar and should get antipsychotics.” Many docs are concerned weight gain and diabetes caused by the drug may be worse in children than adults.

Lilly “has no plans at this time to execute a broad promotional campaign” for Zyprexa in children, spokeswoman Carole Puls wrote Bloomberg in an e-mail. The company will “inform doctors who treat adolescents” about the new data.

In 2003, Zyprexa accounted for 32 percent of all U.S. antipsychotic prescriptions and 15 percent of pediatric orders, according to Wolters Kluwer. But by last year, its share of the US market was down to 15 percent overall and just 4.9 percent of prescriptions for children. Expanded approval is unlikely to change this trend because of concerns about side effects, analysts say.

US sales of antipsychotics grew 74 percent from 2002 to 2006 to reach $11.5 billion. That was fueled partly by a 40-fold rise in children diagnosed with bipolar disorder, or manic depression, over 10 years, according to a study published this month. The number of scrips for US kids doubled to 4.4 million from 2003 to 2006, according to Wolters Kluwer. Risperdal led the way, growing 58 percent to 1.9 million orders. Seroquel and Abilify soared to 1 million scrips each. Only Zyprexa had declining sales for US youth.

Under FDA rules, Lilly will get an extra six months of protection from competing generics for conducting pediatric studies. That’s worth about $1 billion in revenue, says Robert Hazlett, an analyst with BMO Capital Markets in New York. Bristol-Myers is seeking approval to sell Abilify to children, and its application may be reviewed by year-end, spokesman Jeffrey Macdonald says. AstraZeneca is testing Seroquel in youngsters and hasn’t decided whether to apply, says spokesman Jim Minnick.