Sanofi to Advance New Version of Lantus into Late-Stage Development in Early 2012

While Lantus (Sanofi’s insulin glargine) is the current standard for basal insulins, companies are still investing significant efforts to develop even better long-acting insulins. In clinical trials, Novo Nordisk’s new insulin called degludec provided similar improvements in blood glucose control as Lantus, with less hypoglycemia and more flexible dosing. Novo submitted degludec for regulatory review last month in the US and in Europe, placing potential approval in the second half of 2012 (see our NewNowNext in diaTribe #37). Lilly is developing its own version of insulin glargine and has hinted that it could potentially be safer and/or more effective than Lantus. In addition, Lilly is also developing a novel basal insulin of its own. The company is currently recruiting for two phase 3 trials for its insulin glargine product and intends to start phase 3 trials for its novel basal insulin by year end, placing approval for the two products as early as 2014 if everything goes as planned. Earlier this month, Sanofi announced that it will be advancing a new version of Lantus into phase 3 trials in early 2012, which by our estimates would place approval as early as 2014 if all goes accordingly – before Lantus’ patents expire in 2015 in the US. The company has disclosed very few details about the new formulation, but emphasized that it will have a different clinical profile than Lantus – whether this means it will have a longer duration of action, have improved stability or less hypoglycemia, enable more flexible dosing, or provide some other novel feature remains to be seen. Exciting times ahead for those using basal insulin – improved options appear to be well along their way. –VW