Lilly withdraws FDA application

Lilly has said it has pulled its application for US Food and Drug Administration (FDA) approval of its Cymbalta depression treatment.

It is hoped resubmission would be in the first half of 2009, following data from a recently completed study on chronic osteoarthritis knee pain.

The decision by the FDA does not affect other approved uses for major depressive disorder and generalised anxiety disorder.

Lilly said: “In discussions between Lilly and the FDA, agency reviewers raised questions about efficacy and dosing that revolved primarily around statistical methodology and study design.”

John Hayes, a vice-president at the company’s research laboratories, said the organisation believes the updated data package will give the agency a “broader basis” for reviewing its application.

Last week, Lilly announced it is to partner with Chi-Med subsidiary Hutchison MediPharma to undertake drug discovery and development.

The agreement will see the companies studying oncology-related pharmaceuticals, adding to existing targets being developed.

Chief scientific officer of Chi-Med and chief executive of Hutchison MediPharma Samantha Du said “We enjoy working together and today’s announcement demonstrates how productive our collaboration has been.”

Founded in 1876, Lilly is headquartered in Indianapolis, US and employs approximately 40,217 people worldwide.