A Long-acting injection (LAI) formulation of olanzapine under the trade name Zyphadhera(TM) recommended for European approval for the maintenance treatment of schizophrenia in adults.

The Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve the injection form of olanzapine, known as Zyphadhera™ and produced by Eli Lilly and Co. The LAI formulation would be available as maintenance treatment for adult patients with schizophrenia who had previously used the oral formulation during acute episodes.

The CHMP opinion was based on a comprehensive data package of eight studies, with a total of 2,054 patients. The data package included two double-blind studies and six open-label studies.

Further, Lilly has proposed a comprehensive risk minimization plan for identifying and managing Post-Injection Delirium/Sedation Syndrome (PDSS) as part of the marketing authorization in Europe, since, as of August 31, 2008, some PDSS events across all clinical trials were found. The plan includes a requirement for a post-injection observation period described in the product labeling, and an extensive healthcare provider training and educational program.

One of the main difficulties of schizophrenia medication is patients’ low adherence to treatment and limited depot formulations. The LAI formulation combines olanzapine with pamoic acid and delivers the first for a period of up to four weeks.

Olanzapine LAI has just been approved for use in New Zealand and independent regulatory reviews of olanzapine LAI applications for schizophrenia are ongoing in the United States, Canada, Australia and other countries. Olanzapine was first introduced in 1996, and has been prescribed to more than 26 million people worldwide.

The European Commission is expected to have a decision by the end of 2008.

Source: Eli Lilly and Company