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.
Eli Lilly ($LLY) has similar plans to boost its diabetes business with an experimental long-acting insulin, meaning more than one major drugmaker could be chasing Sanofi for a share of the lucrative market.
- here's the company's release
- see Reuters' article