FDA panel votes 8-4 for Novo Nordisk diabetes drug
WASHINGTON (AP) — A panel of federal health advisers recommended Thursday that the government approve an experimental, long-acting diabetes drug from Danish drugmaker Novo Nordisk, but also requested additional safety testing.
The Food and Drug Administration's panel of endocrinology experts voted 8-4 in favor of approval for Novo Nordisk's degludec. The FDA is not required to follow the group's advice, though it often does.
The group's endorsement came despite some concern about potential heart safety side effects with the drug. Citing inconclusive evidence on the problem in company trials, the panelists voted unanimously that the drugmaker should be required to conduct a definitive cardiovascular study of the drug.
Patients with diabetes either do not produce enough of the hormone insulin or do not use it efficiently, allowing excess sugar, or glucose, to accumulate in the blood. Degludec is a new type of insulin designed to help diabetics control their blood sugar levels beyond the standard 24-hour period offered by current products on the market.
Shares of Novo Nordisk A/S jumped $10.89, or 7.3 percent, to close at $159.75 in U.S. trading on heavy volume.