FDA Rejects Oral Treatment for Type 1 Diabetes
22 Marzo 2019 - 1:43PM
Noticias Dow Jones
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 maria.armental@wsj.com
(END) Dow Jones Newswires
March 22, 2019 15:28 ET (19:28 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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