FDA Rejects Oral Treatment for Type 1 Diabetes - Update
March 22 2019 - 7:57PM
Dow Jones News
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)
Copyright (c) 2019 Dow Jones & Company, Inc.
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