- The briefing documents posted on FDA’s website include results from the two Phase III trials with the lixisenatide/Lantus® combination, not previously published
- US regulatory decisions on lixisenatide and the lixisenatide/Lantus® combination are expected in July and August 2016, respectively
Copenhagen, 23 May 2016 – Zealand announces that the US Food and Drug Administration (FDA) today has made briefing documents on lixisenatide and the lixisenatide/Lantus® combination available on its website. The documents relate to the upcoming meeting of the Endocrinologic and Metabolic Drugs Advisory Committee, scheduled by the FDA for 8:00 am to 5:00 pm ET on 25 May 2016 to discuss the New Drug Applications (NDAs) for the two drug products intended for the treatment of adults with Type 2 diabetes. The NDAs were submitted by Sanofi.
The briefing documents contain the key points for discussion at the Advisory Committee meeting and background information on lixisenatide and the lixisenatide/Lantus® combination. This include the results from Sanofi’s two clinical Phase III trials with the lixisenatide/Lantus® combination, LixiLan-L and LixiLan-O, which have not previously been published. The briefing documents can be accessed under the following link: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm491062.htm
Lixisenatide is a once-daily GLP-1 receptor agonist, invented by Zealand and with global development and commercial rights licensed to Sanofi. The lixisenatide/Lantus® combination is a fixed-ratio combination of lixisenatide and basal insulin glargine (100 U/mL), developed by Sanofi under the license agreement with Zealand.
Sanofi submitted the US NDA on lixisenatide in July 2015 and it was accepted by the FDA for regulatory review in September 2015. A regulatory decision on lixisenatide is expected in July 2016. In December 2015, Sanofi submitted the US NDA on the lixisenatide/Lantus® combination product, redeeming a Priority Review Voucher with the submission. In February the FDA accepted the NDA for priority review with a regulatory decision expected in August 2016.
