News

Canagliflozin diabetes drug backed for US approval

A new, experimental diabetes drug from Johnson and Johnson has been ruled safe and effective for treatment of type 2 diabetes by health regulators in the United States.
Following recent safety concerns surrounding canagliflozi, a panel of diabetes experts for the US Food and Drug Administration (FDA) assessed the relative risks and benefits of the drug and voted 10-5 in favour of it being put forward for approval.
Canagliflozin belongs to a new group of oral drug treatments for type 2 diabetes called SGLT2 inhibitors, which work by preventing glucose from being reabsorbed by the kidneys and thus causing more glucose to be removed from the blood and excreted via the urine.
The panellists said the drug could be useful in combination with existing diabetes medications. However, the majority recommended that J&J be required to monitor the low levels of heart attack, stroke and urinary tract infections seen in the first year of testing to see if these problems persist or worsen over the long term.
Dr. Abraham Thomas of the Henry Ford Hospital said: “There are definitely benefits to this drug, but there are also risks. I still have concerns, as many other do.”
J&J said in a statement that it was “pleased” with the panel’s vote and will continue working with the FDA to make canagliflozin the first drug of its type to reach the US market.
A decision on whether to approve sales of canagliflozin in America is expected to be made by the health regulator body by March 29th. The agency is not required to follow the advice of its advisory panel but usually does so.

To Top