After an exhaustive 21-month review, the FDA has extended its approval for the blockbuster new type 2 diabetes drug Victoza (liraglutide). And the news quickly spurred shares of Novo Nordisk higher.
Victoza was approved for Europe last summer (and in Japan last week) and the manufacturer doesn't plan on wasting any time in getting the new drug out onto the hugely important U.S. market. Company execs tell Dow Jones that the treatment will be sold for $8 per 1.2 mgs compared to $4.3 for the same quantity in Europe.
Victoza wasn't an easy sell to regulators. The FDA's expert committee split their vote on the new drug, concerned that the therapy was linked to a higher risk of tumors in lab animals. But the drug offers some distinct advantages over standard therapy. It doesn't risk pushing blood sugar too low and there's clear evidence that the drug triggers weight loss.
In recognition of the cancer worries, the FDA will require a label warning regarding the risk of thyroid cancer. But analysts believe that the drug will achieve blockbuster status nevertheless in the U.S., where annual sales could peak at around $1.33 billion.
"We are convinced that Victoza will prove to be a valuable treatment option for people with type 2 diabetes in the U.S.," says Lars Rebien Sorensen, president and CEO. "The ability of Victoza to substantially improve glucose control with a low risk of hypoglycemia creates an opportunity for more patients with type 2 diabetes to achieve their individual treatment goals."
And there's more research work being done. Just last October Novo Nordisk unveiled a new set of data demonstrating that Victoza is far more effective than Roche's Xenical in cutting weight and reducing blood pressure. The approval is also good news for researchers at Glaxo, Roche and Ipsen, who have other GLP-1 drugs in the pipeline. "This approval removes much of the uncertainty around the GLP-1 class in the U.S.," analysts at Jefferies note.
- check out the Novo Nordisk's release
- here's the Dow Jones report