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Novo’s Weekly Insulin Denied Approval as FDA Requests More Information

Novo Nordisk branding. Photographer: Sergei Gapon/AFP/Getty Images (Sergei Gapon/Photographer: Sergei Gapon/AFP/G)

(Bloomberg) -- Novo Nordisk A/S’s once-weekly insulin failed to get approval from US regulators Wednesday after the government asked for more information in order to complete its review.

The company said the US Food and Drug Administration asked for details on the manufacturing process and the type 1 diabetes indication.

Novo said it’s evaluating the content of the Complete Response Letter and plans to work closely with the agency to fulfill the requests, although the company doesn’t expect to finish them this year. The denial comes after an advisory panel voted against approving the medicine in May, citing risks of low blood sugar and the need for more clinical trials.

The shares were little changed in early trading in Copenhagen. Novo has climbed about 40% this year, buoyed by the rising potential of the market for its obesity drug Wegovy. The global market for weight-loss drugs may reach $150 billion by 2035, Berenberg analyst Kerry Holford wrote in a note. 

Though the new obesity drugs are driving Novo’s growth, insulin has been the company’s core product for a century. People with type 1 diabetes depend on injected insulin to regulate the sugar in their blood more than those with the more common form — known as type 2 — because their pancreas no longer produces the hormone.

The weekly insulin won regulatory approval earlier this year for both types of diabetes in Canada and in Europe, where it goes by the brand name Awiqli. In China, it was cleared for type 2 diabetes. Novo has said the longer-acting treatment will help reduce the need for daily injections and reduce waste from injection pens.

In the US, about 1.7 million people have type 1 diabetes, according to the Centers for Disease Control and Prevention. Two-thirds of them used insulin pumps as of 2021, which means they wouldn’t need to use a weekly injection. The pumps use short-acting insulin, essentially mimicking the mechanism of the pancreas.

--With assistance from John Lauerman and Lisa Pham.

(Updates with shares in the fourth paragraph.)

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