FDA’s made briefing documents on lixisenatide and the lixisenatide/Lantus® combination product
Zealand announces that the US Food and Drug Administration (FDA) 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.
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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.
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.
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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.