FDA rejects long-acting version of Zyprexa

pharmafile | February 29, 2008 | News story | Sales and Marketing  

Lilly has suffered a setback after the US medicines regulator rejected a new version of its top-selling product Zyprexa.

The atypical antipsychotic is the world's biggest selling treatment for schizophrenia, but is approaching the end of its patent life. The new product Zyprexa LAI is an injectable form of the drug which can be administered just once every four weeks.

A long-acting injection would help extend its patent life and also prove very helpful for doctors and patients, whose condition can return if they fail to take pills regularly.

But the FDA says 'excessive sedation' occurring in about 1% of patients is of concern, and has issued the drug with a Not Approvable letter.

Dr Jennifer Stotka, head of US Regulatory Affairs at Eli Lilly, said the company was disappointed at the decision, but hoped that the drug can eventually be approved.

"Given the chronic and severe nature of schizophrenia, persistent challenges with adherence, and the limited number of approved depot formulations, we continue to believe that, if approved, Zyprexa LAI would provide a valuable treatment option for patients suffering from schizophrenia," she said.

Zyprexa LAI is also being appraised by the EMEA in Europe and regulators in Canada and Australia.

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