FDA Approves Toujeo, Basal Insulin Seen as Successor to Lantus

The FDA on February 25, 2015, approved the basal insulin Toujeo, which Sanofi sees as a successor to Lantus to treat patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM). Toujeo, insulin glargine [rDNA origin], is administered in a 300 U/mL dose once a day in a disposable, prelled pen.¹

The approval in the United States was viewed as a mixed blessing for Sanofi, as analysts noted that FDA did not permit a label that highlighted Toujeo’s lower rate of hypoglycemia than Lantus in clinical trials.² By contrast, the European Medicines Agency touted this benet in granting its approval 2 days later.³

In its press release for the American market, Sanofi stated only, “All studies of the EDITION program successfully met the primary study endpoints by demonstrating similar blood sugar control with Toujeo as compared to Lantus.”¹ The older insulin, which had its patent expire in February, has been a mainstay for Sano for more than a decade. Other options have entered the market, notably Afrezza, the inhaled insulin that took 3 attempts to win FDA approval.⁴ (Sanofi paid $225 million to Afrezza maker MannKind at the end of 2014 for a licensing agreement for commercial, regulatory, and development activities for the drug.)⁵

Common adverse events reported for Toujeo (excluding hypoglycemia) included nasopharyngitis (12.8% in T1DM patients and 7.1% in T2DM patients) and upper respiratory tract infection (9.5% in T1DM patients and 5.7% in T2DM patients).¹

FDA approval was based on results from the EDITION trial program, which was comprised of a series of international phase 3 studies that evaluated the efcacy and safety of Toujeo in more than 3500 adults, including both T1DM and T2DM patients. The trial compared a once-daily dose of Toujeo with the once-daily dose of Lantus, an injection that is only 100 U/mL of insulin glargine, a factor that FDA later noted.2 Patients were followed in the open-label, randomized, active-control, parallel, treat-to-target studies of up to 26 weeks, with 6 months’ safety extension.¹

The market for insulin is potentially huge. The International Diabetes Federation estimates that more than 370 million people worldwide have diabetes, with nearly 95% suffering from T2DM, which is linked with numerous other comorbidities including obesity.²

REFERENCES

1. Sanofi receives FDA approval of once-daily basal insulin Toujeo [press release]. Paris, France: PRNewsire; February 25, 2015. http://www.news.sanofi.us/2015-02-25-Sanofi-Receives-FDA-Approval-of-Once-Daily-Basal-Insulin-Toujeo.

2. Berkrot B. Sanofi’s diabetes drug Toujeo gets US approval, label disappoints. Reuters website. http://www.reuters.com/article/2015/02/26/us-sanofi-sa-diabetes-toujeo-idUSKBN-0LU13I20150226. Published February 26, 2015. Accessed February 27, 2015.

3. Hirschler B. Sanofi diabetes drug Toujeo wins EU green light, pricing in focus. Reuters website. http://uk.reuters.com/article/2015/02/27/us-sanofi-sa-diabetes-europe-idUKKBN0LV1AQ20150227. Published and accessed February 27, 2015.

4. Kam K. Afrezza’s initial sales create buying opportunity. Forbes website. http://www.forbes.com/sites/kenkam/2015/02/27/afrezzas-initial-sales-create-buying-opportunity/. Published and accessed February 27, 2015.

5. Forster C. Analysts weight in on MannKind following Q4 results. Seeking Alpha. http://seekingalpha.com/article/2961216-analysts-weigh-in-on-mannkind-following-q4-results?app=1&auth_param=r9ntj:1af3gt5:30510d62341274229ced294c8921bb9e&uprof=53&dr=1. Published and accessed February 28, 2015.

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