European Health Regulators Approve Oral Treatment for Type 1 Diabetes

By Maria Armental

European health regulators have approved a pill that offers a chance to reduce the number of daily insulin injections for people with Type 1 diabetes, according to Sanofi SA and Lexicon Pharmaceuticals Inc.

Zynquista, which contains the active substance sotagliflozin, has been as a once-a-day pill to use with insulin therapy to help manage blood-sugar levels for those with a body mass index of at least 27.

U.S. health regulators last month rejected a similar application. Though the companies didn't specify the reason, a Food and Drug Administration advisory panel in January cast a split vote on whether Zynquista's benefits outweighed its risks.

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.

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

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

Shares in Lexicon are up 13% to $6.75 in after-hours trading, while American depositary receipts in Sanofi were flat. In regular trading, Lexicon shares rose 5.1% while Sanofi ADRs were up 3.4%.

Write to Maria Armental at [e-mail]

(END) Dow Jones Newswires

April 26, 2019 17:06 ET (21:06 GMT)

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