European Health Regulators Approve Oral Treatment for Type 1 Diabetes
April 26 2019 - 5:21PM
Dow Jones News
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 maria.armental@wsj.com
(END) Dow Jones Newswires
April 26, 2019 17:06 ET (21:06 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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