A request to the FDA by advocacy group Public Citizen to pull the Victoza diabetes treatment threw Novo Nordisk's ($NVO) shares for a loop Friday, beating them down by nearly 2 percent on the Dutch exchange before the Danish company came back swinging.
The petition to the FDA suggests the risks of thyroid cancer, pancreatitis and kidney failure far exceed any benefits from a drug it says is not needed given that there are lots of alternative treatments for type 2 diabetes. Citing internal documents it had gotten its hands on, Public Citizen pointed out that the agency had given approval to Victoza over the recommendation of 3 reviewers.
But within hours, the company fought back, dismissing Public Citizen's evidence as outdated and off the mark.
Novo Nordisk's Chief Science Officer Mads Krogsgaard Thomsen told Reuters: "We do not expect any consequences for Victoza from Public Citizen's petition. There is nothing in it."
"In the two years since Victoza was approved, Novo Nordisk has continued to work closely with the FDA and the medical community to monitor the benefits and appropriate use of Victoza," Novo said in a statement. "Our experience in those two years does not support the Public Citizen call to deprive patients of the benefits of Victoza."
The FDA did add warnings last year to Victoza tying it to pancreatitis, thyroid cancer and renal failure, points out Pharmalot.
And that relationship with the FDA has recently paid off. Just last week, the company was given approval to put on its label that its has outperformed other treatments. The change came after a study showed it outperformed Merck's ($MRK) Januvia at controlling blood sugar and helping patients lose weight.
The diabetes market is growing fast, as obesity in the U.S. contributes to rising rates of the disease, and increasing wealth in the developing world fuels diabetes development there. In addition to competing with Januvia, Novo's once-daily Victoza faces the weekly injectable Byetta and its even longer-lasting variant Bydureon.
Novo shares in the U.S. were down only slightly in early trading Friday.
- here's the Reuters story