U.S. regulators hit Denmark's Novo Nordisk ($NVO) with a three-month delay on the agency's decision on whether to approve
Tresiba, a long-acting insulin that could rival Sanofi's ($SNY) blockbuster Lantus.
Novo said on Friday that U.S. regulators have extended their review of the diabetes drug to consider additional data that was requested from the drugmaker,
delaying the agency's decision on the application until October 29.
"During the review period the FDA has asked for further data clarification
and analyses," the company stated. "In response, Novo Nordisk 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 NDAs. The
agency has not requested additional clinical trials."
As Reuters reports, the new FDA action date will come along with the
agency's decision on a related diabetes product called Ryzodeg. With the two
drugs, Novo has big plans to continue its own rapid expansion in the
fast-growing diabetes market, building on the company's core insulin business.
And the company has already launched a major recruiting effort to build its
commercial operations in the U.S. to aid in the market onslaught. But the
smallest regulatory delays, even if they don't adversely impact chances of
approval, can be extremely costly and unwelcome.