Novo ready to rev up Tresiba for European launch

Novo Nordisk ($NVO) is ready to roll with its new diabetes drug Tresiba--in Europe, at least. The company won regulatory approval for the potential blockbuster yesterday, setting up a mano-a-mano fight with Sanofi's ($SNY) long-dominant treatment, Lantus.

Tresiba's European debut will be gradual, with Denmark--Novo's home country--and the U.K. first on the list for launch. The rest of the EU will follow in the latter half of 2013 and into 2014, the company says. A combo version, Ryzodeg, pairs the solo drug's active ingredient with Novo's fast-acting insulin analog NovoLog; its launch will follow about a year later.

So Tresiba will be like a snowball rolling downhill toward Lantus, rather than an immediate avalanche. That's something of a reprieve for Sanofi, which garnered more than $5 billion off Lantus in 2011, and another $4.8 billion for the first 9 months of 2012. Even better, Europe isn't Lantus' biggest market. That's the U.S., by far, and Tresiba is still waiting on approval from the FDA.

For Novo, the European approval is another score, following up a nod from Japanese regulators late last year. The Danish company has been counting on Tresiba to power near-term growth. Analysts have pegged peak sales at $3.5 billion by 2025.

Whether the EMA's blessing augurs approval from FDA is another story. In the wake of the Avandia safety scandal, U.S. regulators have raised the bar for diabetes drugs. Agency reviewers zeroed in on Tresiba's cardiovascular risks in advance of an advisory panel meeting in November--and though the panel voted 8-4 in favor of Tresiba's approval, it also unanimously recommended follow-up safety studies.

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