Please login to the form below

Not currently logged in
Email:
Password:

Boehringer - Lilly file empagliflozin for European approval

EMA begins review of the companies' new type 2 diabetes drug

Empaglifozin moleculeThe European Medicines Agency (EMA) has begun its review of Boehringer Ingelheim and Lilly's new oral type 2 diabetes drug empagliflozin.

The treatment is a sodium glucose co-transporter-2 (SGLT-2) inhibitor, the same new class of type 2 diabetes treatment as Bristol-Myers Squibb and AstraZeneca's Foxiga and Johnson & Johnson's canaglifozin.

SGLT-2 inhibitors work independently of insulin and appear to provide sustained improvements in blood glucose, whilst also alleviating the weight gain seen with other oral anti-diabetic agents (OADs).

“We are pleased the EMA has accepted our marketing authorisation application for a potential new treatment option to help patients better manage their type 2 diabetes mellitus,” said Prof Klaus Dugi, corporate senior vice president medicine, Boehringer Ingelheim.

The European filing follows empagliflozin's recent submission to US regulators for approval, giving it a chance to catch up with its rival SGLT-2 inhibitors.

Bristol-Myers Squibb and AstraZeneca's Forxiga (dapagliflozin) has already been approved in the EU, but delayed in the US, while Johnson & Johnson's canagliflozin has been filed for approval in the US and Europe.

Empagliflozin is one of the four compounds covered by Boehringer and Lilly's 2011 co-development agreement.

Early this year Lilly took back sole development and marketing rights to LY2605541 - a basal insulin product, but the partners are still working together on Tadjenta (linagliptin) and LY2963016, a second basal insulin analogue.

28th March 2013

From: Sales

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Ashley Communications

Ashley Communications is a unique medical communications consultancy providing outstandingdirector-only service tailored to individual client needs. The company philosophy is...

Latest intelligence

Online Physician Communities
Doctors.net.uk expands its online educational resources for doctors
Includes video for three procedures that all doctors are expected to be able to do...
Online Physician Communities
Review: diabetes tweetchat
Some of the key points from the recent #M3diabetes tweetchat held by PMLiVE and M3 Europe...
access denied
Sales reps struggle to access doctors
Doctors continue to turn away from face-to-face visits from pharma sales reps and look instead towards mobile technology for information...