The Zyprexa Chronicles: Zyprexa Set For Teen Approval

And just in time for the new school year.

Pharmalot has news that an FDA official has overturned objections of colleagues, who recommended not approving a new indication for Zyprexa, and set the drug on its way for almost-certain approval by the agency for use in pediatric cases. It's not clear to me exactly what age range that means, but we'll see when the FDA's approval comes.

Go read Pharmalot for a good rundown of many issues in this case, including news that the drug fattened up almost half the patients in a short period of time. What's also interesting to me is that the approval trials were done in Russia. Several FDA officials noted internally that Lilly's ease ay rounding up research subjects in Russia struck them as suspicious.

I find it galling that given just how much is now known about injuries caused by this drug--known to anyone with eyes that can read--that the FDA would feel comfy approving the drug. Or that one official would overturn the recommendations of colleagues. Perhaps the agency is trying to drum up business for the its adverse events reporting unit. Whatever.

Once the drug is approved, it ought to be interesting to see how Lilly handles marketing the drug to doctors and how it counteracts the drug's negative press (not to mention a growing set of accusations in lawsuits filed against the company by nine states), especially since docs have steered away from prescribing the drug in adults.

From Bloomberg:

"'These medications may help some patients, but I'm worried FDA approval may lead to rampant prescription writing,' said Steven Klotz, a child psychiatrist in Harrisburg, Pennsylvania. 'I don't want drug reps telling pediatricians every adolescent that throws a tantrum is bipolar and should get antipsychotics.'"

You can vote on whether you think Zyprexa should be approved for teens over at Pharmalot.