Eli Lilly gets bonus with FDA's Zyprexa Relprew approval

The US Food and Drug Administration last month approved drug major Eli Lilly's Zyprexa Relprew (olanzapine), a new extended release injectable version of its blockbuster drug Zyprexa for the treatment of schizophrenia in adults.

This is good news for the company, say analysts at Zacks Equity Research, because the new version carries its own patent and may act as a cushion to Zyprexa's sales when the main patent expires in 2011. However, the approval comes with the requirement of patient monitoring by health care professionals for three hours after they get the injection to watch for signs of mild to severe sedation or delirium.

Lilly said that it worked with the FDA to develop a Risk Evaluation and Mitigation Strategy (REMS), which includes a communication plan, a patient medication guide and a mandatory Patient Care Program, which restricts distribution of Zyprexa Relprew to prescribers, health care facilities, pharmacy service providers and patients enrolled in the program. The goal of the Patient Care Program is to mitigate the risk of negative outcomes associated with the new product.