Sanofi
says LixiLan diabetes drug trials meet targets
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[June 13, 2016]
PARIS (Reuters) - France's Sanofi
said on Sunday that two late-stage Phase III clinical trials of its
LixiLan diabetes drug had met their targets, readying it for approval in
the United States in August and Europe early next year.
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LixiLan consists of a single-injection combination of Lyxumia, a
drug developed with Danish drugmaker Zealand Pharma, and Sanofi's
Lantus. It targets patients suffering from type 2 diabetes.
"Both studies met their primary endpoints, demonstrating
statistically superior reduction of HbA1c (average blood glucose
over the previous three months) with the titratable fixed-ratio
combination versus comparators," Sanofi said in a statement.
Sanofi said the results, unveiled at a meeting of the American
Diabetes Association, had been included in regulatory submissions to
the U.S. Food and Drug Administration and the European Medicines
Agency.
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The company expects the drug to be approved in August in the U.S.
and during the first quarter of 2017 in Europe.
LixiLan sales are expected to reach around $1 billion in 2020,
according to consensus forecasts compiled by Thomson Reuters
Cortellis. The medication is likely to compete with NovoNordisk's
Xultophy.
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Nearly 400 million people worldwide have diabetes, with type 2
accounting for more than 90 percent of cases. Without proper
treatment or lifestyle changes, those numbers are expected to grow
substantially in the coming years.
(Reporting by Matthias Blamont; Editing by James Regan)
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