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Spurning panel endorsement, FDA rejects Novo's long-acting insulin Tresiba

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The FDA has handed Novo Nordisk ($NVO) a stunner, ordering the pharma company to complete a new cardiovascular safety study of the long-acting insulin Tresiba before it can be approved in the U.S. The decision on Tresiba, coming just a few weeks after the Europeans gave the treatment a green light, underscores just how high the FDA sets the bar on safety for diabetes treatments, which are aimed at masses of patients and come from a drug development field noted for past horror stories.

Just about everyone expected U.S. regulators to require Novo to do another safety study, but only after it hit the market. A solid majority of the FDA's panel of experts endorsed the approval of Tresiba, and all of them asked for a study post-approval. The agency, though, pushed that recommendation aside in demanding decisive proof of safety first, rather than after, an OK.

There's no absolute timeline to go on from here. Most analysts don't expect Novo to have the data in hand before 2015 or even 2016, offering Sanofi ($SNY) more years to sell its blockbuster Lantus without a challenge from Tresiba. Lantus earned about $6.6 billion last year. The news could also be good for the likes of Eli Lilly ($LLY), which has gambled heavily on its own late-stage diabetes program in search of elusive blockbuster meds.

Shares of the pharma company dived early, plunging 12% as investors reacted to the bitter taste of the news. The FDA's complete response letter also caught Novo's related Ryzodeg in the regulatory net. And the regulators also want Novo to clear up an earlier warning letter related to manufacturing.

"We are convinced that Tresiba and Ryzodeg offer significant benefits for people who require insulin," said Lars Rebien Sørensen, chief executive officer of Novo Nordisk. "We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review."

The setback for Novo clearly underscores the deep-seated fear that a diabetes application can stir in the FDA. That's one reason why the field has become one of the most expensive in R&D, requiring huge studies and often years in delays. For smaller biotech companies, that can make raising new funds for diabetes research difficult and sometimes impossible.  That situation just got appreciably worse with the news from Novo.

- here's the press release
- read the story from The New York Times
- get Bloomberg's report

Special Report: Top diabetes drug pipelines of 2012

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