J&J’s new diabetes drug may pose heart risks, says FDA

Hannah Blake

pharmaphorum

The US Food and Drug Administration (FDA) has said that Johnson &amp, Johnson’s new diabetes drug, which is currently being evaluated in clinical trials, may raise the level of bad cholesterol in patients and may also pose heart risks. However, the regulators said that the studies met goals showing the drug was effective at lowering blood-sugar levels.

This was announced in documents published by the FDA on Tuesday 8th January.

The drug, canagliflozin, is being tested to treat patients with type 2 diabetes. The drug is part of a new class of diabetes medication, which is known as SGLT2 inhibitors. These drugs work by blocking reabsorption of glucose by the kidneys and increases glucose excretion in urine to lower blood sugar.

Diabetes affects approximately 370 million people across the world, with around 90% of the cases being type 2. As part of the FDA’s regulatory requirements, companies making treatments for diabetes must prove that their drugs do not increase the risk of heart problems, including heart attacks.

On Thursday 10th January, the FDA’s endocrinologic and metabolic drugs advisory committee (an independent, non-medical panel of experts) will review and vote on canagliflozin’s safety, efficacy and approval. The FDA usually follows this panel’s recommendation. If approved, J&amp,J will sell the drug as Invokana.

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Related news:

FDA Says J&amp,J Diabetes Drug Effective, Cites Concerns (Wall Street Journal)

FDA staff say J&amp,J’s new diabetes drug may pose heart risks (Reuters)

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