FDA Says No to Novo Nordisk’s New Insulin Products

Andrew Klips  |

Shares of Danish drugmaker Novo Nordisk (NVO) are trading lower Monday morning after the U.S. Food and Drug Administration issued a Complete Response letter to Novo Nordisk requesting more information on Tresiba and related product Ryzodeg before it will complete its review of the two long-lasting insulin drug candidates for diabetes.  Novo originally submitted the NDA in September 2011.

Novo Nordisk received the letter on February 8, but waited until Sunday to make it public.

Tresiba is an insulin designed to last at least 42 hours to help diabetes patients control their blood sugar, far greater than the 24-hour span of current insulin on the market today.

Novo Nordisk, the world’s largest insulin manufacturer, said that the FDA wants to see more information on cardiovascular data, meaning that Novo Nordisk will have to perform extra studies on heart risks, something it will probably not be able to complete until at least 2015, according to the company.

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The FDA also noted in its letter to Novo Nordisk that it would not approve the drugs until the company complies with a warning letter that it was issued in December pertaining to the company’s Novo Alle, Bagsvaerd Denmark factory.  In that letter, the FDA said that an investigation of the facility “identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”

Investors were betting that Novo Nordisk would get the nod to proceed with Ryzodeg and Tresiba, also called degludec, after the drugs were approved in Europe, Mexico and Japan.  Further inspiring optimism of FDA approval, in November last year and FDA advisory panel voted 8 to 4 in favor of approval of Tresiba, although the panel unanimously advised that additional research needs to be conducted to properly assess cardiovascular concerns after marketing approval.

The news of initial rejection by the FDA has shares of NVO trading about 13 percent lower at $167 in early Monday morning trading, even though Novo Nordisk said that it doesn’t think the news will have any significant impact on its financial results in 2013.  Analysts were expecting that big things from the drugs, anticipating that they would add nearly $3 billion annual to sales by 2017 for Novo Nordisk.

The news has boded well, however, for rival insulin-maker Sanofi SA (SNY), whose shares have jumped ahead by about 3 percent in early trading to $48 each.

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