Please login to the form below

Not currently logged in
Email:
Password:

Sanofi uses priority review voucher for diabetes combo

LixiLan in race with Xultophy in bid to hit US market first

Sanofi reception 

Sanofi has used an FDA priority review voucher for diabetes combination LixiLan, trying to get its nose in front in a race to market with Novo Nordisk.

The French pharma group paid $245m for the voucher - which cuts four months of the FDA's usual review time - in a deal with Retrophin earlier this year.

Sanofi clearly sees a big benefit if it can bring LixiLan - a combination of its long-acting Lantus (insulin glargine) product and GLP-1 agonist lixisenatide - to the US market ahead of Novo Nordisk's rival Xultophy (insulin degludec/liraglutide).

Xultophy was launched in Europe earlier this year and is currently under review by the FDA after being submitted for approval in September with a standard 10-month review time. Sanofi's product is currently known as LixiLan in Europe and is due to be filed early next year - at the moment neither a European nor a US trade name has been selected.

With $8bn-a-year Lantus already facing biosimilar competition in some markets, LixiLan is seen as a key product for Sanofi as it defends its basal insulin franchise. In trials, the combination product met the primary objective of superior reductions in haemoglobin A1c (HbA1c) - a measure of glucose control over time - compared to Lantus alone.

"A large unmet medical need still exists for people with type 2 diabetes, as more than half are not at their blood sugar goal despite using oral medications or insulin," commented Pierre Chancel, who heads Sanofi's global diabetes unit.

"We recognise the need for additional treatment options and look forward to working with the FDA during their consideration of our submission," he added.

Lixisenatide is a once-daily GLP-1 agonist that was invented by Zealand Pharma and has been sold by Sanofi as Lyxumia since 2013. In the same year, Sanofi withdrew its marketing application for the drug after it became clear the FDA would need additional data, but the firm refiled the dosser in September.

Article by
Phil Taylor

24th December 2015

From: Research

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
M&F Health

M&F Health is a full service communications agency, dedicated to the health and wellbeing sector. We are an independent amongst...

Latest intelligence

Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham
Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...
NHS medicines optimisation milestone
Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare Consulting Team, explore the implications of Adalimumab’s recent European patent expiry...

Infographics