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Sanofi announced Friday that its next-generation basal insulin Lantus XR (insulin glargine), which is marketed as Toujeo in theUS, Europe and Canada, gained Japanese regulatory approval for the treatment of type 1 and type 2 diabetes. Pierre Chancel, who heads Sanofi's global diabetes division, said "this first approval in Asia adds to the momentum of an active launch year, and it highlights our commitment to improving diabetes care worldwide."
The company said the decision was supported by data from the Phase III EDITION programme comparing Lantus XR against Sanofi's older insulin Lantus in more than 3500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy. According to Sanofi, the clinical programme, which included the EDITION JP 1 and JP 2 studies involving over 450 Japanese patients, showed that Lantus XR demonstrated a "favourable" efficacy and safety profile.
The new-generation insulin, which is currently under review by other regulatory authorities around the world, is available in the US, Germany, Denmark and the Netherlands and "will become available in other countries in the coming months," Sanofi said.For more click here
Source: First word pharma