Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News Lilly hopes new data will support Cymbalta resubmission

Lilly hopes new data will support Cymbalta resubmission

4th June 2009

Lilly believes the data it is submitting as part of its supplemental new drug application (sNDA) for Cymbalta (duloxetine HCl) will further strengthen its request.

The company had originally submitted the paperwork to the Food and Drug Administration (FDA) in the second quarter of 2008 but after discussing the study design and statistical methodology with the regulatory body, it decided to withdraw it.

Now the resubmission ? which Lilly had hoped would take place in the first half of this year ? is based on a recent study in chronic pain due to osteoarthritis.

Dr John Hayes, vice-president of the company’s research laboratories, explained at the time of the initial application, the additional data about chronic osteoarthritis and low back pain was not available.

“We believe including these new data in the updated sNDA package will provide a broader clinical basis for the FDA to review the application,” he said.

Last month, the European Medicines Agency’s committee for medicinal products for human use granted Lilly with a positive recommendation for the administration of Almita (pemetrexed for injection) as a treatment for locally advanced or metastatic non-small cell lung cancer.

We currently have 9 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.