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New diabetes drug almost approved, but will it affect your heart?
A drug that gives you 24-hour insulin coverage?
That's the issue at hand for the FDA, whose Endocrinologic and Metabolic Drug Advisory Committee voted yesterday to recommend approval for the drug Tresiba early next year. Tresiba is a long-acting insulin that could be prescribed for both type 1 and type 2 diabetes.
Great for insulin, bad for heart?
The problem, however, is that the committee also voted unanimously on another thing: They're not sure the heart risks associated with the drug have been tested enough for it to reach the hands of consumers just yet.
Committee member Dr. Brendan Everett, a cardiologist at Brigham and Women's Hospital, says that it may not be safe:
"I don’t know that what we’ve seen (in terms of a cardiovascular signal) is real, but I have enough concerns about it that I would want to know the answer before a large number of patients with diabetes take this medication."
A proposal for further studies
Novo, the company behind Tresiba, proposed a study to assess the potential risks, which would include 7,500 patients over a five-year period. However, the panel hasn't decided on whether the tests will take place before or after the drug is put on the market.
Tresiba has already been approved in Japan and has come with a positive recommendation from Europe, but it remains to be seen whether or not the FDA will move forward with approval before more safety tests are done. Ed Hendricks, a panelist and medical director at the Center for Weight Management in Roseville, California, explains:
"We have a concerning signal, but it’s not of a degree that we insist that this drug be abandoned and not be approved, but it’s of sufficient degree that we insist more patients be looked at."
Approval will most likely happen within the next six to 12 months.
Sources: Business Week, Forbes
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