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Despite a split ruling on the safety of a new diabetes drug by the US Food and Drug Administration’s advisory panel, Danish drug manufacturer Novo Nordisk is still hopeful that the agency will approve its liraglutide.
The company has asked the FDA for approval of liraglitude, an injectable drug for type 2 diabetes, which works by disrupting the body’s ability to break down carbohydrates and control blood sugar. However promising the drug was in tests in controlling blood sugar levels and reducing weight, FDA panelists still had doubts and voted 6 to 6 on whether to approve the drug or not, as there is evidence it caused cancerous thyroid tumours in rats and mice tested with it.
“It is very rare for a drug that has caused tumors in two species, in both genders at clinically relevant exposures to be approved,” said FDA drug reviewer Karen Mahoney.
Novo however argued that although liraglitude spurs tumor growth in rodent cells, there is no comparable reaction in humans.
But analysts weren’t so optimistic about the future of the drug. Jack Scannell, a Sanford C. Bernstein & Co. analyst in London, in a note to clients, wrote: “The votes were bad. Commercial reality is probably worse. It is hard to see a good way forward with respect to thyroid risk.”
Novo shares fell as much as 13 percent on Friday after the FDA panel’s split vote.
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