Novo Nordisk ($NVO) has a key part of its future diabetes business on the line next month. The FDA wants experts at a planned committee meeting Nov. 8 to weigh signs of cardiovascular risks associated with its blockbuster hopeful degludec against benefits of the long-acting insulin therapy. And the stakes are high for Novo as the Danish drugmaker targets the U.S. market for the therapy to bolster its standing in the competitive diabetes arena.
Novo has endured delays in the U.S. review of degludec, which is the drugmaker's best shot at wresting market share away from Sanofi's ($SNY) dominant therapy Lantus in the long-acting insulin category. The FDA is known for its vigilance on heart safety of new therapies and particularly diabetes meds that patients may take for a long time. Degludec, which is under review in the U.S. and Europe, has been associated with higher cardio risks compared with similar therapies, as the FDA noted in a document from earlier this month.
As Bloomberg reports, Novo's shares dipped today the most since Aug. 4, 2011, on communications from the company to investors that the FDA committee will take a close look at the cardiovascular risks of degludec. The agency will consider the committee's advice in its decision on whether to approve the therapy in the U.S., a hot spot in the global diabetes epidemic and the largest market for therapies. That means much of Novo's blockbuster ambitions for the therapy, which is already approved in Japan, rest on the FDA's decision.
Novo, of course, believes it has a winner on its hands. In addition to the OK to sell the therapy in Japan, European Medicines Agency experts last week endorsed approval of the treatment for the European Union. And analysis from studies shows lower risks of hypoglycemia in patients on the drug.
"We are confident Tresiba offers very real and needed clinical advantages for patients," Mike Rulis, a spokesman for the Bagsvaerd, Denmark-based company, said in a phone interview today with Bloomberg. "Cardiovascular risk is a hot topic with the FDA these days," and it's not surprising it will be discussed, he said, as quoted and paraphrased by the news service.
Nothing threatens the prospects of a new diabetes therapy under review at the FDA like cardiovascular risks. And Novo must make a strong case for the benefits of the therapy to win over risk-averse reviewers.
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