Zealand announces that the FDA Advisory Committee voted for US approval of iGlarLixi, the fixed-ratio combination of lixisenatide and Lantus®

• The members of the Advisory Committee voted 12-2 for an approval of iGlarLixi
• Both lixisenatide and iGlarLixi for the treatment of type 2 diabetes were discussed at the Advisory Committee meeting. The FDA had not requested a vote on lixisenatide
• FDA regulatory decisions on lixisenatide and iGlarLixi are expected in July and August 2016, respectively   
• Zealand reiterates its financial guidance for 2016, including expectations of increasing royalty revenue and additional milestone revenue of DKK 200 million / EUR 27 million

Copenhagen, 26 May 2016 - Zealand announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) has discussed lixisenatide and  iGlarLixi for the treatment of adults with type 2 diabetes. Following the discussions, the Advisory Committee members voted 12 to 2 (with 1 non-vote) to recommend approval of the New Drug Application (NDA) for iGlarLixi in the US. The Advisory Committee was not asked by the FDA to vote on the approval of the NDA for lixisenatide. 

Lixisenatide is a once-daily prandial GLP-1 receptor agonist, invented by Zealand with global development and commercial rights licensed to Sanofi. IGlarLixi is a fixed-ratio combination of lixisenatide and basal insulin glargine 100 Units/mL (marketed as Lantus^®), developed by Sanofi under the license agreement with Zealand. The NDAs for both products are undergoing regulatory review and a decision by the FDA is expected for lixisenatide in July 2016 and for iGlarLixi in August 2016.

In a comment, Britt Meelby Jensen, Chief Executive Officer of Zealand, said: "I am very pleased that the FDA Advisory Committee so clearly has recommended an approval of iGlarLixi in the US as a new treatment for adults with type 2 diabetes. This positive outcome, and the supportive conclusion on lixisenatide as a stand-alone therapy, have taken us an important step closer to potentially having two medicines based on a Zealand invention being available on the US market later this year."                           

She continued: "The prospect of growing royalty revenue from lixisenatide and iGlarLixi is an important element in the execution of our strategy of building a portfolio of proprietary Zealand products to support accelerated value creation. Our portfolio includes ZP1848, a novel GLP-2 analog, which is in Phase II development for short bowel syndrome, and ZP4207, a glucagon in Phase II as a single-dose version for severe hypoglycemia in diabetes and in preparation for Phase II as a multiple-dose version for use in a dual-hormone artificial pancreas device. All programs are advancing as planned and we look forward to updating the market on further news in the coming months."

Vedhæftede filer:

19-16_0526 - FDA AdComm outcome on lixi and iGlarLixi - ENG_FINAL.pdf