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Novo Nordisk nabs European OK on blockbuster diabetes drug hopeful

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The EMA approved Tresiba and Ryzodeg--courtesy of Novo Nordisk

Lars Sorensen's plans to build Novo Nordisk ($NVO) into one of the world's biggest drugmakers got a big boost with the news that the European Commission has approved Tresiba, its long-acting insulin, which will now be positioned as a rival to Sanofi's ($SNY) megablockbuster Lantus. Novo also gained approval in Europe for the insulin Ryzodeg.

Novo plans to roll out Tresiba (insulin degludec) in the U.K. and Denmark in the first half of 2013 while prepping for a launch in the rest of Europe in the second half. Ryzodeg will follow Tresiba's launch in about a year. Tresiba is under regulatory review at the FDA after winning an advisory committee vote supporting its approval in the U.S.

"These marketing authorizations constitute significant milestones for Novo Nordisk and the treatment of diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, in a statement. "We look forward to making Tresiba and Ryzodeg available to many people with diabetes in Europe."

Executive VP and Chief Science Officer Mads Krogsgaard Thomsen--courtesy of Novo Nordisk

Last November the FDA's outside experts on diabetes voted 8 to 4 in favor of an approval, but also unanimously asked for a cardiovascular outcomes study after noting staff concerns about a heart risk signal detected during trials. The FDA hates to see any significant cardiovascular risk associated with new diabetes treatments. And it's not cheap to explore. A new study could cost around $250 million. The discussion about the cardio study triggered considerable speculation among analysts whether the FDA would require the study before or after an approval, with some analysts fretting that any mention of heart risks on the label could significantly impair the blockbuster revenue that has been forecast for this product.

Tresiba is considered a hot contender to take on Lantus, which provides $5 billion a year in revenue to Sanofi. The once-daily insulin also was less likely to trigger hypoglycemia, or dangerously low blood sugar.

- here's the press release
- here's the Reuters report

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