COPENHAGEN (Reuters) - Novo Nordisk’s liraglutide drug is safe and effective enough to warrant approval for use in chronically obese patients with at least one weight-related health issue, an advisory panel to the U.S. Food and Drug Administration (FDA) said on Thursday.
The positive vote sent shares in the company, the Nordic region’s most valuable by market capitalization, to an all-time high on Friday, up more than 3 percent.
The company must still await final FDA approval for the drug.
Chief science officer Mads Krogsgaard Thomsen made the following comments in a Reuters interview:
“This has been our first shot at goal, but it has also been an indicator for whether Novo Nordisk really is able to increase our focus in this area.
“We are ready to roll up our sleeves and increase the research within this field.
“There’s no doubt that this is an actual focus area for the company.
“We start at full tilt and are already a bit in front of our competitors, because technologically and biologically this is very close to what already is on our home ground.”
“The potential patient group is very large. In the U.S. around 100 million people are obese and around a fourth of them are so severely obese that they have diseases in connection with the obesity such as pre-diabetes.
“We don’t just aim for obese patients, we aim for people with complications connected to their overweight.
“Sure, not all the 25 million people have equal access to health insurance etc.
“We say this has blockbuster potential” (sales of $1 billion a year within 8-10 years of launch).
“You will have to agree with the different health insurance companies, whether the drug should be sold with a discount.
“The list price will be high, and then we will negotiate from case to case, but this will not be a super cheap treatment.”
“You can never say anything for sure, that lesson we have unfortunately learned. I don’t think there was anything during the debate that pointed toward a rejection, but you cannot say anything until you have a letter from FDA.”
“As it looks now, the deadline for the FDA is Oct. 20. If we get an approval by then, within the next six month the drug can be on the market, more precise we cannot be at this moment.
“If all goes well we can have a European approval, which could make a launch in the first countries in 2015.”
Reporting by Stine Jacobsen, editing by Terje Solsvik