FDA Rejects Oral Treatment for Type 1 Diabetes

By Maria Armental 

A proposed oral treatment for Type 1 diabetes in adults has been rejected in the U.S.

The rejection of what would have been the first oral treatment for Type 1 diabetes in the U.S. is a big setback for Lexicon Pharmaceuticals Inc. , a small company based in a Houston suburb that currently has one product on the market and losses of nearly $1.5 billion as of Dec. 31. Lexicon is developing the treatment, which is called Zynquista, with French pharmaceutical giant Sanofi.

On Friday, the Food and Drug Administration issued what's known as a complete response letter, which indicates that an application cannot be approved in its present form.

Sanofi and Lexicon said in a statement they will work with the FDA to determine the next steps for Zynquista, which contains the active substance sotagliflozin. The companies had proposed that the drug be used in combination with insulin to help manage blood-sugar levels.

Lexicon's shares were recently down about 29% to $5.63 in Friday afternoon trading after being halted earlier in the day, while Sanofi's American depositary receipts were down 2% at $44.37.

Lexicon's market valuation stood at about $800 million as of Friday, according to FactSet data.

Sanofi declined to comment further. A representative from Lexicon couldn't immediately be reached for comment.

The FDA's decision follows an agency advisory panel's split vote in January on whether Zynquista's benefits outweighed risks to support approval.

A similar panel in Europe has recommended approval for overweight or obese patients, though noted the higher risk of diabetic ketoacidosis, a life-threatening complication caused by a lack of insulin in the body.

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.

Those with Type 1 diabetes require 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 [e-mail]

(END) Dow Jones Newswires

March 22, 2019 15:28 ET (19:28 GMT)

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