Novo Nordisk ($NVO) is wrestling with the FDA over its long-acting insulin, Tresiba, in the U.S., but has found believers in Japan. Regulators there have given initial approval to Novo's Ryzodeg, a combo of Tresiba and its fast-acting insulin NovoRapid. Japan approved Tresiba, or degludec, in September, becoming the first country to do so.
Nova must still get final approval for Ryzodeg from Japan's Ministry of Health, Labor and Welfare, which it said it expected to receive within a few months. The news excited Nordea Bank AB analyst Mikkel Pedersen, who Bloomberg says wrote in a note, "We see a lot of exciting share price drivers ahead and expect the stock to take off in 2013 and set records."
In November, an FDA advisory committee voted 8-4 to recommend that the FDA approve Tresiba, Novo's potential blockbuster, which some expect could throw up significant competition to the market-dominant Lantus from Sanofi ($SNY). But the same panel also threw some cold water on Novo's hopes by voting unanimously to suggest that Novo be required to conduct a cardiovascular outcomes study on its heart risks.
Denmark-based Novo, the world's largest insulin maker, said it expected the study to cost $256 million. Analysts have noted that a warning for heart risks on Tresiba's label would likely dampen sales in the U.S., the largest potential market for Tresiba and Ryzodeg.
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