COPENHAGEN -(Dow Jones)- Novo Nordisk A/S (NVO), the world's largest producer of diabetes drugs, has played down concerns that U.S. approval of its Victoza diabetes drug for the treatment of obesity could be delayed, financial daily Boersen reports Monday.
Following the report, Novo Nordisk's shares rose sharply, after closing lower Friday.
Victoza, which boosts insulin generation, has been found in trials to be effective in the treatment of obesity and Novo Nordisk has launched an independent trial program for the drug for this indication, with the aim of receiving U.S. approval by 2014. But Nordea analyst Michael Novod wrote in a note Friday that the process could be delayed by two to three years due to an expected tightening in the documentation requirements for diet and obesity drugs.
Novo Nordisk Chief Science Officer Mads Krogsgaard Thomsen told Boersen he doesn't expect any delays in the approval process, however, because data from the studies of Victoza as a diabetes drug can be re-used in the documentation required for the obesity-drug approval process.
An expert panel on Thursday agreed to recommend that the U.S. pharmaceutical drugs regulator, the FDA, require obesity-drugs to be submitted to studies that specifically document the risks of suffering coronary incidents.
Tighter documentation requirements could only delay the approval "in a scenario where the FDA radically changes approach and declares that the patient population we are studying--which is diabetic as well as overweight--isn't relevant," Krogsgaard Thomsen told Boersen.
At 1415 GMT, Novo Nordisk's shares were up 4.6%.
Newspaper web site: www.borsen.dk
-By Flemming Emil Hansen, Dow Jones Newswires; +45 33 12 44 88; email@example.com
(END) Dow Jones Newswires
April 02, 2012 11:19 ET (15:19 GMT)
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