FDA panel recommends J&J’s diabetes drug for approval
The US FDA Endocrinologic and Metabolic Drug Advisory Committee has voted 10-5 in favour of Johnson &, Johnson’s diabetes drug, canagliflozin. This positive recommendation comes just after a statement from the FDA at the beginning of the week, which said that canagliflozin may pose heart risks. However, the panel weighed the relative risks and benefits of canagliflozin, especially in relation to any potential it might have to increase the risk of heart attack or stroke, and came to the conclusion that the overall risk benefit profile was acceptable.
The panel has also stated that longer-term data will be needed to fully assess the impact on patients of the higher LDL cholesterol levels as they were unable to determine conclusively that the imbalance in cardiovascular events seen in the first 30 days during clinical trials was a statistical anomaly.
The FDA is set to rule on whether to approve the drug by March 29th. While the agency is not required to follow the panel’s recommendation, it usually does. If approved, J&,J are set to sell canagliflozin under the brand name Invokana.
F.D.A. Advisory Panel Votes to Approve Diabetes Drug (New York Times)
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