COPENHAGEN, June 8 Danish drugmaker Novo Nordisk
, the world's biggest insulin maker, said on Friday
that U.S. health regulators have extended their review of
ultra-long-acting insulin products Degludec and DegludecPlus by
three months to consider further data.
A decision on the review of the drug candidates to treat
type 1 and type 2 diabetes is now expected on Oct. 29.
The U.S. Food and Drug Administration asked for further data
clarification and analyses, and the company has submitted a
substantial amount of additional data.
"Due to the size and timing of these submissions the FDA
considers them as major amendments to the (new drug
applications)," the company said in a statement, adding that the
agency had not requested additional clinical trials.
Novo Nordisk has also filed for approval of the two products
with the European Medicines Agency and regulators in Japan,
Canada, Switzerland and some other countries, it said.
It first filed for approval with the FDA in Sept. 2011.