Sanofi sees FDA approval for diabetes drug
pharmafile | February 26, 2015 | News story | Sales and Marketing | Afrezza, FDA, Q2, Sanofi, Twitter, diabetes, insulin glargine, q4
US regulators have approved Sanofi’s diabetes treatment Toujeo which is said to be a follow-up to the French firms key performing insulin product Lantus.
The FDA approved Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), a once-daily long-acting basal insulin to improve glycemic control in adults living with type 1 and type 2 diabetes.
“Sanofi is proud of its long heritage in diabetes and insulin therapies, including Lantus which has supported patients in the management of their diabetes for more than a decade. With the FDA approval of Toujeo, Sanofi builds on its strong legacy and looks forward to bringing a new treatment option to people living with diabetes,” says Pierre Chancel, senior VP of Sanofi’s diabetes unit.
Expected to be available in the US at the beginning of Q2 this year, Toujeo’s nod was based on an FDA review from a trial evaluating its efficacy in more than 3,500 adults from diverse diabetes populations (type 1 and type 2).
In a clinical trial programme leading to the US nod, once-daily Toujeo was compared to once-daily Lantus (insulin glargine [rDNA origin] injection, 100 U/mL) in open-label, randomised, active-control, parallel, treat-to-target studies of up to 26 weeks of duration with six months safety extension.
Sanofi’s recent sales were driven by strong performances by the pharma division’s diabetes products, which were up 11% in the fourth quarter of 2014, and to which Lantus contributed €1.8 billion in sales.
It also recently launched its inhalable insulin Afrezza in the US to control blood sugar in people with type 1 and type 2 diabetes, following FDA approval in June after acquiring the global rights from the manufacturer Mannkind in a $925 million deal.
But now Toujeo is considered the most important offering in Sanofi’s pipeline, and the company will be expected to try and convert patients from Lantus to its successor as quickly as possible, what with the older drug now about to lose patency in the US.
Brett Wells
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