Eli Lilly confident about Olanzapine approval

Eli Lilly has expressed its confidence that Olanzapine will be able to help schizophrenic people should it receive approval.

In a statement, Eli Lilly said that it is working on a proposed Risk Evaluation and Mitigation Strategy for submission to the US Food and Drug Administration (FDA), which is now reviewing the company’s Olanzapine long-acting injection (LAI).

The treatment is already approved under the name Zypadhera for use in the European Union and New Zealand.

Eli Lilly also said that no further clinical trials are necessary for the FDA’s looking-over of the new drug application and that the group has made its response letter.

The company explained that the LAI is intended for treating adults with schizophrenia in acute and maintenance terms.

Todd Durell, associate medical director for US neuroscience at the company, stated: “We cannot speculate on the timing of a potential decision, but remain confident that, if approved, the long-acting depot formulation of olanzapine will offer an important option for treating this devastating and chronic illness.”

Meanwhile, Eli Lilly has announced the date for a conference call outlining its 2008 financial results.

The call will be held on January 29th and can be accessed through a live webcast on the company’s website.