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 The panel voted 16-0 that the Food and Drug Administration should
approve the drug, iDegLira, for patients with type 2 diabetes. The
FDA is not obliged to follow the advice of its advisory panels but
typically does so.
IDegLira combines Novo Nordisk's diabetes drug Tresiba, also known
as insulin degludec, with its GLP-1 agonist Victoza, or liraglutide.
Clinical trials showed the drug helped patients control their blood
sugar and did so with one injection rather than two.
On Wednesday, the committee will discuss a similar drug, iGlarLixi,
made by Sanofi SA, which combines the company's experimental GLP-1
agonist lixisenatide with its insulin product Lantus.
The drugs, if approved, would be the first two products with
different mechanisms of action in a single, fixed-ratio combination
injection. The companies aim to show that treating diabetes earlier
and more aggressively will stave off complications from diabetes
such as heart disease and blindness.
FDA reviewers said the drug may look more effective in clinical
trials than in practice because of the way the trials were designed,
adding that greater convenience could come at the price of reduced
dosing flexibility. Panelists said the drug's benefits outweighed
those concerns.
"I feel this does bring a new, useful treatment option," said Dr.
Robert Smith, a professor of medicine at Brown University and
chairman of the panel.
The panel struggled to precisely define which patients iDeGlira
would be most useful for but agreed it would at least be appropriate
for patients who were previously taking either insulin or a GLP-1
drug.
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There was less clarity about the drug's usefulness in patients who
had not previously taken one of those drugs. Some panel members said
they would be reluctant to start a patient on two new drugs at once.
But certain patients in this group, such as those who were
needle-shy, could benefit, they said.
Dr. Todd Hobbs, U.S. chief medical officer for Novo Nordisk, said
the company was "extremely pleased" with the panel's recommendation.
"This is an important milestone for healthcare providers and
patients," he said.
Panel members recommended the agency ensure that the drug's label
makes clear that the injection contains two drugs.
Diabetes affects more than 22 million people in the United States,
according to federal data.
(Reporting by Toni Clarke in Washington; Editing by Peter Cooney and
Jonathan Oatis)
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