While it is still waiting on a decision from the FDA, Denmark's Novo Nordisk ($NVO) has been granted Japanese approval for its long-acting insulin Tresiba, a drug that could possibly rival Sanofi's ($SNY) blockbuster Lantus.
In June, U.S. regulators asked for more data on Tresiba. Then in July, the FDA decided to schedule an advisory panel review for the long-acting insulin on Nov. 8, past the current PDUFA date. Lantus generates about $5 billion a year, and analysts have suggested that Novo's drug could rival that. But now the company will have to wait until early next year to see what the FDA will do.
The company also is awaiting the agency's decision on a related diabetes product called Ryzodeg. With the two drugs, Novo has big plans to continue its own rapid expansion in the fast-growing diabetes market, building on the company's core insulin business. And the company has already launched a major recruiting effort to build its commercial operations in the U.S. to aid in the market onslaught.
Eli Lilly ($LLY) has similar plans to boost its diabetes business with an experimental long-acting insulin, meaning more than one major drugmaker could be chasing Sanofi for a share of the lucrative market.
Analysts have said the market for diabetes treatments could hit $54 billion annually by 2020 as the population in the West gets older and fatter and as healthcare reform in the U.S. gets more people access to new and better drugs.
- here's the release
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