FDA Panel To Review Long-Acting Form Of Lilly’s Zyprexa
Tuesday, December 18, 2007
A Food and Drug Administration panel will review an application for a proposed, long-acting form of Eli Lilly & Co.'s (LLY) top- selling drug Zyprexa on Feb. 6, the agency said Tuesday.Zyprexa is currently approved as an oral, once-daily medication to treat schizophrenia and bipolar disorder. The drug had $3.5 billion in sales during the first nine months of 2007. There's also a short-acting injectable form of Zyprexa that's use to treat agitated, non-cooperative patients with schizophrenia or bipolar mania, usually in an emergency setting.
Lilly is seeking FDA approval of the long-acting form of Zyprexa for the treatment of schizophrenia, which could be injected given every two or four weeks. The product would be administered in a doctor's office.
Schizophrenia is a chronic, severe and disabling brain disorder that affects the way people think and afflicts about 1% of Americans. According to the National Institute of Mental Health, people with schizophrenia may hear voices other people don't hear or they may believe that others are reading their minds, controlling their thoughts or plotting to harm them. The disorder is typically diagnosed in the late teens or 20s.
The FDA said the main safety issue that will be considered with the long- acting form of Zyprexa is the occurrence of "severe somnolence," or sleepiness, in some patients who've been given the drug.
The matter will be reviewed by outside medical experts who serve on the agency's psychopharmacologic drugs advisory committee, who are also expected to make recommendations about whether it thinks the FDA should approve the product. The FDA usually accepts its committee's advice but is not required to.
Charles McAtee, a Lilly spokesman, said the company has submitted a "robust" package in support of long-acting Zyprexa, but said there's a possibility that a small number of patients could be temporarily sedated after receiving an injection.
He noted that a common problem is that many patients with schizophrenia either don't remember or won't take their current medications on a daily basis.
Posted in Dangerous Drugs • Zyprexa