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Novo Nordisk Falls on FDA Insulin Review

From Associated Press (November 6, 2012)

WASHINGTON -- Shares of Danish drug maker Novo Nordisk plunged Tuesday after U.S. drug regulators raised safety questions about the company’s experimental long-acting insulin for patients with diabetes.

THE MOVER: The Food and Drug Administration posted its preliminary review of Novo’s degludec, which is designed to help diabetics control their blood sugar levels beyond the standard 24-hour period offered by other insulins. Agency scientists say company studies of the drug detect a possible risk of heart problems. On Thursday the FDA will ask a panel of outside experts to assess the risk and whether the company’s analysis addresses the issue. The FDA is not required to follow the group’s advice, though it often does.

THE BIG PICTURE: Degludec is one of several new diabetes treatments designed to help patients better control their blood sugar. Studies of the drug conducted by Novo have showed it compares favorably with Sanofi’s Lantus, the top-selling insulin in the world. The FDA is expected to issue a decision on the drug in coming weeks.

SHARE ACTION: U.S.-listed shares of Novo Nordisk A/S fell $14.53, or 9.1 percent, to $145.09 in afternoon trading. Over the past year, they have traded between $105.86 and $170.27.

Posted: November 2012