UPDATE: Sanofi's likely blockbuster insulin Toujeo wins FDA approval
- The FDA on Wednesday granted approval to Sanofi's insulin glargine Toujeo, the successor to its flagship blockbuster insulin Lantus.
- Toujeo has been approved for type 1 and type 2 diabetic adults.
- In a statement, the company said that the drug will launch in the U.S. in Q2. A Sanofi spokesperson told BioPharma Dive that the company is aiming for a launch sometime around April.
“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," said Sanofi Global Diabetes SVP Pierre Chancel in a statement. "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."
This is a huge deal for Sanofi. Lantus, grappling with patent expiration and competition from biosimilars, will no longer be able to provide the company the sky-high revenue stream that Sanofi's become accustomed to, making Toujeo's launch particularly critical.
The company said as much during the JP Morgan Healthcare conference last month, asserting that Sanofi would be putting its full marketing force behind Toujeo—not too much of a surprise considering that's what is necessary to carve out a space in an increasingly crowded diabetes field and staunch the bleeding from flagging Lantus sales. One analysis by EP Vantage predicts that Toujeo sales could near the $1.7 billion mark by 2020, while Credit Suisse pegs it at a more optimistic $2 billion by 2018.
One bit of news that may make Sanofi feel more confident about Toujeo's chances? Eli Lilly's announcement earlier this week that the company would be delaying regulatory filings for its long-acting insulin candidate for several years due to adverse effects. But it will still face plenty of competition from companies like Novo Nordisk, which has already been eating away at Lantus sales.