Health and Healthcare

FDA Diabetes Treatment Vote to Determine the Fate of Lexicon Therapeutics?

Chris Lange

Published: January 18, 2019 11:06 am

Last Updated: January 31, 2020 1:49 am

Lexicon Pharmaceutics Inc. (NASDAQ: LXRX) shares fell on Friday after the U.S. Food and Drug Administration (FDA) voted to approve the firm’s type 1 diabetes treatment. Although the result from this committee was mixed, it seems to be a case of sell the news.

The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted eight to eight on the question of whether the overall benefits of Zynquista (sotagliflozin) outweighed the risks to support approval.

Sotagliflozin is an investigational oral dual SGLT1 and SGLT2 inhibitor under regulatory review as an adjunct to insulin for the treatment of adults with type 1 diabetes. While the FDA is not required to follow the committee’s vote, the agency considers the committee’s recommendations when making its decision, which is anticipated by March 2019.

Rachele Berria, MD, Ph.D., global vice president and head of Diabetes Medical Affairs, Sanofi, commented:

We believe in the overall benefit-risk profile of sotagliflozin for adults with type 1 diabetes who lack adequate glycemic control using insulin alone. We will continue to work with the FDA through its review process to hopefully bring to patients a new treatment that can help people living with type 1 diabetes control their blood sugar and address some of the challenges of insulin-only therapy.

Shares of Lexicon were last seen down 21% at $6.05, in a 52-week range of $5.29 to $13.97. The consensus analyst price target is $29.67.

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