Drug Approvals

FDA denies Lexicon appeal of drug rejection

Dec 03, 2019

Lexicon Pharmaceuticals has failed in its efforts to appeal a rejection from the FDA for its diabetes drug, Zynquista.

The agency declined to approve Zyquista in March after independent FDA advisors raised concerns that the medication could trigger diabetic ketoacidosis, an often fatal condition that causes a buildup of ketones in the body. 

Lexicon co-developed Zyquista alongside Sanofi SA, who ultimately dropped out of the partnership in July.  

Zyquista belongs to a class of SGLT inhibitors and was developed to treat type 1 diabetes, but Lexicon is hoping to win approval for the drug for type 2 diabetes and potentially other indications as well.

Despite the new rejection, Lexicon said it will continue to work with the FDA to reappeal the decision and is looking for a new partner to bring the drug to market.

News of the appeal denial sent shares for Lexicon plummeting by 18 percent Monday.

Read the Reuters report.

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