Novo Nordisk A/S (NVO) Sticks to Target for First-Half Tresiba Approval in U.S.  
1/31/2013 7:42:00 AM

Novo Nordisk A/S (NOVOB), the world’s largest insulin maker, stuck to its target of getting U.S. approval for the diabetes treatment Tresiba in the first half as it’s counting on the product to reach higher 2013 forecasts. The Danish company is making progress on talks with the U.S. Food and Drug Administration on Tresiba and will need to do a study about cardiovascular effects once the medicine is on the market, Chief Executive Officer Lars Sorensen said on a conference call with reporters today. Novo has no indications it would be required to do another study before approval, he added. That would have meant a delay for the diabetes treatment. Novo aims for the product to eventually become the world’s top-selling long-acting insulin, overtaking Sanofi (SAN)’s Lantus, which garnered 3.92 billion euros ($5.3 billion) in sales in 2011. Bagsvaerd, Denmark-based Novo lifted its 2013 revenue and profit forecasts today on higher demand for its existing diabetes treatment Victoza and the introduction of Tresiba. The required study will begin “imminently, as we start marketing” the medicine, Sorensen said. The FDA hasn’t told Novo when its review will end. Novo will be able to start selling Tresiba in the U.S. “almost immediately” after FDA approval, he said. Tresiba Label: Heart risks with Tresiba, also known as insulin degludec, probably aren’t enough of a concern to block its approval, an advisory committee with the FDA ruled in November. Sorensen declined to comment on negotiations over the drug’s label with the FDA. A medicine’s label highlights its risks and a warning on a label can impact its sales. U.S. approval of Tresiba is “critical,” Brian Bourdot and other analysts at Barclays Plc’s investment-banking unit in London, wrote in a Jan. 25 note to clients.