FDA to decide on Sanofi diabetes combo
pharmafile | February 22, 2016 | News story | Research and Development, Sales and Marketing |Â Â Lantus, SanofiÂ
Sanofi will be looking to August for a decision on its new type 2 diabetes combo LixiLan (lixisenatide and Lantus), after the US FDA accepted its New Drug Application (NDA) today on a priority review basis.
This NDA submission for the fixed-ratio combo is based on data from two Phase 3 studies of more than 1,900 patients insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively.
Results show the LixiLan combo was superior at lowering of average blood glucose levels (HbA1c), compared with both treatment with lixisenatide (Lyxumia) and compared with treatment with insulin glargine (Lantus) in type 2 diabetes patients treated with metformin. Data will be presented at a medical congress in 2016, Sanofi says.
“The FDA filing notification is an important milestone for Sanofi as we work to broaden our diabetes portfolio,” comments Pascale Witz, executive vice president, Global Diabetes & Cardiovascular, Sanofi. “Physicians may need to consider fasting and mealtime blood glucose imbalances in their overall management of diabetes, and additional treatment options are needed. We look forward to working with the FDA during the review process with a view toward bringing this investigational medicine to adults with type 2 diabetes in the US.”
The company also added that it plans to submit the combination to European regulators in March 2016.
Lixisenatide, a GLP-1 receptor agonist, was created by the Danish company Zealand Pharma, which licensed development and commercialisation rights to Sanofi. The drug was evaluated in patients with type 2 diabetes and was accepted for review by the FDA as a monotherapy in September 2015. Based on the standard review timeline of 10 months, the regulator is expected to make a decision in July 2016.
Joel Levy
Related Content
Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria
Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee …
Sanofi’s treatment granted orphan designation for rare chronic inflammatory condition
The European Medicines Agency has granted orphan designation to Sanofi’s investigational Bruton’s tyrosine kinase (BTK) …
Sanofi completes acquisition of Vigil Neuroscience to early neurology pipeline
Sanofi has announced that it has finalised its acquisition of Vigil Neuroscience, a US-based biotechnology …
