FDA Rejects Oral Treatment for Type 1 Diabetes - Update

Date : 03/22/2019 @ 11:57PM
Source : Dow Jones News

FDA Rejects Oral Treatment for Type 1 Diabetes - Update

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By Maria Armental 

A pill that potentially offered a chance to reduce the number of daily insulin injections for people with Type 1 diabetes was rejected for sale in the U.S.

The Food and Drug Administration on Friday issued a complete response letter, which indicates that a new drug application cannot be approved in its present form, for Zynquista.

French drugmaker Sanofi SA and Lexicon Pharmaceuticals Inc., a small biopharmaceutical company based in a Houston suburb, sought approval for Zynquista for use in combination with insulin to help people manage their blood-sugar levels.

The companies didn't indicate why the FDA rejected their application Friday, but an agency advisory panel in January cast a split vote on whether the benefits of Zynquista, which contains the active substance sotagliflozin, outweighed its risks to support approval.

Concerns focused on the "consistent and clinically meaningful increase in the risk of diabetic ketoacidosis," a life-threatening complication caused by a lack of insulin in the body, according to a panel report. A similar panel in Europe also noted the higher risk of diabetic ketoacidosis but ultimately recommended approval for overweight or obese patients.

The rejection of what would have been the first oral treatment for Type 1 diabetes in the U.S. is a setback for Lexicon, which has one product on the market and losses that far outstrip its market value.

Lexicon shares, which plunged as much as 46% during Friday trading, closed down 22% at $6.20. American depositary receipts in Sanofi fell 2.6% to $44.26.

Lexicon Chief Executive Lonnel Coats said during a conference call Friday that the company remains committed to the drug and framed the rejection as a temporary setback.

Type 1 diabetes, which accounts for about 5% of all diagnosed cases of diabetes in the U.S., is an autoimmune condition caused by the body attacking itself and destroying the cells in the pancreas that make insulin.

The disease was once commonly referred to as insulin-dependent diabetes because it requires lifelong insulin therapy to manage blood-glucose levels.

Sanofi is also looking at sotagliflozin to treat the more prevalent Type 2 diabetes.

Write to Maria Armental at maria.armental@wsj.com


(END) Dow Jones Newswires

March 22, 2019 19:42 ET (23:42 GMT)

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