RPT-Sanofi diabetes drug shown to work as well as Byetta

Mon Jun 27, 2011 6:45am EDT

(Repeats June 24 story for wider readership) (For more on the American Diabetes Association conference, see: [ID:nN1E75N112] )

* Controls blood sugar as well as twice-daily Byetta

* European regulatory filing planned for late 2011

* U.S. regulatory filing planned for second-half 2012

By Deena Beasley

SAN DIEGO, June 24 (Reuters) - A trial of Sanofi's SAN.PA experimental once-daily drug for Type 2 diabetes, Lyxumia, found that it worked as well as Byetta, a similar drug sold by Amylin AMLN.O and Eli Lilly and Co (LLY.N) that is injected twice a day.

The six-month trial involved 634 patients whose diabetes was not adequately controlled by oral drugs or basal insulin.

Sanofi said the trial of Lyxumia, or lixisenatide, met the main goal of showing non-inferiority compared with Byetta, also known as exenatide, in terms of controlling blood sugar, with less risk of low blood sugar.

Sanofi said 2.5 percent of Lyxumia patients had symptomatic hypoglycemia, compared with 7.9 percent of Byetta patients.

Both drugs belong to a relatively new GLP-1 class of drugs that stimulate insulin release when glucose levels become too high.

The French drugmaker licensed Lyxumia from Zealand Pharma (ZELA.CO). The GLP-1 treatment is seen as a possible blockbuster which could help Sanofi reach its goal of becoming the world's top diabetes treatment company.

Sanofi is conducting an extensive clinical program for the drug. Results from six of 10 pivotal trials have so far been reported, according to Dennis Urbaniak, vice president of Sanofi's diabetes division.

He said the company plans to file for regulatory approval of Lyxumia in Europe toward the end of the year and will seek U.S. approval toward the second half of 2012.

In the Byetta comparison trial, the percentage of patients who reached target blood sugar levels was 48.5 for Lyxumia and 49.8 percent for Byetta.

Sanofi also said that mean body weight significantly decreased from baseline in the lixisenatide group compared with the exenatide group (94.5 kg to 91.7 kg with lixisenatide vs. 96.7 kg to 92.9 kg with exenatide).

About 10 percent of lixisenatide patients dropped out of the trial due to side effects (mainly gastrointestinal events including nausea, diarrhea and vomiting), compared with 13 percent of the exenatide group. (Reporting by Deena Beasley, editing by Matthew Lewis)

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