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Home Industry News Sanofi’s Lantus adds new safety data to European label

Sanofi’s Lantus adds new safety data to European label

7th June 2013

Sanofi has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to include new safety data on the EU product label for its diabetes therapy Lantus (insulin glargine).

The revised label will include safety and efficacy data from the insulin glargine cardiovascular outcomes trial Origin, a landmark study spanning seven years that included more than 12,500 patients.

In this study, Lantus was shown to have no effect on the relative risk for cardiovascular disease and cardiovascular mortality when compared to the standard of care, though rates of hypoglycaemic events were higher with insulin glargine.

This new data will help to clarify the safety profile of Sanofi's drug and allows clinicians to make more informed choices when prescribing it.

Pierre Chancel, senior vice-president for global diabetes at Sanofi, said: "Lantus has helped millions of people manage their diabetes for over a decade, resulting in trust and reassurance, which is key to successful disease management."

Earlier this year, the company expanded its portfolio of diabetes therapies with the launch of Lyxumia, a new therapy for type 2 diabetes mellitus.ADNFCR-8000103-ID-801596022-ADNFCR

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