Ever seen a cat toy with its prey? That's how the Food and Drug Administration is treating Eli Lilly
The agency turned down Lilly's marketing application for long-acting Zyprexa in February because of "excessive sedation events" seen in patients taking the drug, but the company's most latest Risk Evaluation and Mitigation Strategy (REMS) seems to have convinced the FDA that it can deal with the issue.
The risk-management tool is basically a plan to keep doctors from prescribing the drug to the wrong patients. REMS can be fairly restrictive, like the one for Elan's
Should it meet the FDA's approval, the long-acting version of Zyprexa probably won't be as successful as its once-daily older brother. For comparison, sales of Johnson & Johnson's
Still, there's a decent market for antipsychotics that don't have to be taken daily, especially in patients prone to going off medication. Risperdal Consta logged sales of nearly $1 billion through the first nine months of last year. In the U.S., Lilly plans to call the long-acting drug Zyprexa Adhera, in the hopes of not-so-subliminally telling doctors that patients will be more likely to adhere to their medication regimen.
Eli Lilly faces a pretty steep patent cliff ahead, but if it can get a few of these delayed drugs past the FDA, and develop ImClone's pipeline successfully, it could land safely on the other side.
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