Johnson & Johnson’s rising star diabetes drug Invokana hit a snag earlier this month when the Food and Drug Administration (FDA) announced it was requiring a warning be added to the drug’s label for the risk of bone fractures and decreased bone density.
The drug safety communication pointed out that a warning for bone fractures was already on the safety labels of Invokana as well as the combination drug Invokana and metformin called Invokamet. But the agency said data from new studies confirmed fractures occurred more often in patients taking Invokana compared to patients taking a placebo. The labels will also include a new warning for bone density loss.
When Invokana was approved by the FDA in March 2013, the agency had required Johnson & Johnson to conduct a two-year study in elderly patients. The results of that study, which involved 714 elderly patients, showed that those taking Invokana lost more bone density in their hips and lower spine than those who took a placebo.
Invokana is in a new class of diabetes drugs known as SGLT2 inhibitors, and is poised to reach blockbuster billion-dollar annual sales status by the end of 2015. However, the new warnings may slow its projected growth.
The same could hold true for another new class of diabetes drugs known as DPP-4 inhibitors, which includes the brand name Januvia. The FDA warned last month that the drugs may cause “severe and disabling” joint pain.
Januvia, as well as a similar class of new diabetes drugs known as GLP-1 agonists, including the brand names Byetta and Victoza, have also been linked to a painful inflammation of the pancreas called pancreatitis, as well as an increased risk for pancreatic cancer.
Source: Fierce Pharma