Dive Brief:
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The FDA announced Thursday it had approved Sanofi's Adlyxin (lixisenatide), a once-daily injection to improve blood sugar levels in adults with type 2 diabetes.
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The approval ends a years-long approval process that was set back after the FDA asked for more information about the treatment's cardiovascular safety.
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The treatment already has been approved for use in more than 60 countries under the proprietary name Lyxumia.
Dive Insight:
This approval has been a long time coming. Sanofi initially prepared to submit the treatment to the FDA in 2013, but pulled its application to complete further studies after the agency asked for more information about the treatment's cardiovascular safety.
The FDA accepted a new submission last September after a trial involving more than 6,000 patients addressed those issues. In addition, the delay gave Sanofi the ability to gather two years of real-world dosing information from patients in the EU, where the treatment already had been widely approved.
Adlyxin will compete with Novo Nordisk's Victoza (liraglutide) and Lilly's Trulicity (dulaglutide). It is designed to increase glucose-dependent insulin production and reduce blood sugar.
Victoza has been a powerhouse for Novo, with $2.64 billion in sales in 2015, a jump of 18% over 2014. The FDA approved Trulicity in September 2014.