FDA Approves New Basal Insulin Toujeo

Quick Hits

Sanofi, which has been bracing for increased competition for Lantus, has won the race to bring a new basal insulin to the marketplace. This week, the drug manufacturer announced the FDA has approved Toujeo, its new once-daily long-acting basal insulin. The new insulin is expected to go on sale in the U.S. by the start of the second quarter of this year.

Studies found that Toujeo’s overall ability to control blood sugar levels matched that of Lantus. It also proved more effective at controlling nighttime hypoglycemia, according to a Bloomberg report. The biggest difference between the two basal insulins is that while Lantus contains 100 units/mL, Toujeo is more concentrated and triples Lantus’ capacity, yielding 300 units/mL. While Lantus is suitable for people with diabetes who are age 6 and up, Toujeo is only approved to treat patients who are 18 years and older.

Interestingly, pharmaceutical market watchers weren’t overwhelmed by the news of Toujeo’s approval, according to a report in Fierce Pharma. One market analyst predicted that many Lantus users will not switch over to Toujeo because they will not see enough difference between the two insulins.

Since Sanofi owns both products, you would think that would be good news, but Sanofi’s profit margin for Lantus has come under threat. Insurance payors are demanding a cut in the price of Lantus in 2015. Also, there is the pending threat of generic versions of Lantus flooding the marketplace. It’s believed that Sanofi must establish a strong foothold with Toujeo in the basal insulin marketplace if it is to maintain its profit margin.

UPDATE – 3/5/15 – EU regulators have given Toujeo the green light in the European marketplace, and allowed the drug’s label to state that the newer basal insulin is more effective at preventing nighttime hypoglycemia than Lantus, according to a Fierce Pharma report.

Craig Idlebrook contributed additional reporting to this article.