FDA says no to long-lasting insulin drugs Tresiba and Ryzodeg

Danish pharma company Novo Nordisk's stock tumbled last month after the U.S. Federal Drug Administration rejected its application to market two new diabetes drugs, despite previous approval by the FDA's own advisory committee. The long-lasting insulin drugs -- Tresiba and Ryzodeg -- have already been approved in the European Union, Japan and Mexico. MarketWatch reports that on February 11, the Monday following the FDA's announcement, Novo Nordisk shares fell by 14 percent in both the New York and European stock exchanges.

PMLiVE states that the FDA issued Novo Nordisk a Complete Response Letter denying approval for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) pending additional safety testing. The FDA's own advisory committee had previously voted 8 to 4 in favor of approving the products with the condition that Novo Nordisk complete additional post-approval testing. The regulator now insists that due to a cardiovascular "safety signal" in the company's dataset, this testing must be completed before introducing the drugs in the U.S. market. That could delay the U.S. launch by at least two years.

According to The Wall Street Journal, Novo Nordisk Chief Executive Lars Rebien Sorensen said the company is "surprised and disappointed" by the FDA's demand for additional testing. A company spokesman, Mike Rulis, said the firm could not provide additional details about the testing or release an updated schedule without first examining the matter. A meeting with the FDA has not yet been scheduled.

The Wall Street Journal estimates this could result in about a $14 billion drop in market value. Diabetes represents one of the pharmaceutical industry's fastest growing markets, accounting for roughly $35 billion worldwide, and it is expected to grow to $58 billion by 2018. Novo Nordisk controlled about 27 percent of that market in 2011. The company doesn't expect the FDA letter to significantly impact 2013 financial results, notes The Wall Street Journal.

PMLiVE reports that the delay could allow competing companies to close the market gap on the company. One of the most notable challengers is Eli Lilly's LY2605541, currently in phase III testing. Tresiba, Ryzodeg and LY2605541 reportedly show advantages over the current leader in long-lasting insulins, Lantus from Sanofi, including a reduced risk of hypoglycemia.

According to PMLiVE, Novo Nordisk expects to launch Tresiba in the UK and Denmark during the first half of this year, and then in other European markets in 2013 and 2014. The FDA's rejection raises questions about the development of another Novo Nordisk combination drug that includes insulin degludec, IDegLira.

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