Johnson & Johnson’s Invokana has suffered a major setback as the FDA strengthened its warnings about the drug’s effect on bone fractures.
The FDA’s warnings state that the drug is related to an increased risk of bone fracture and added new information about its effect on bone mineral density.
Clinical trials of Invokana (canaglifozin) in 714 elderly patients showed that the drug caused a significantly greater loss of bone mineral density at the hip and lower spine than placebo. Fractures occurred as soon as 12 weeks after commencing the drug.
Invokana is a sodium-glucose cotransporter-2 (SGLT2) inhibitor used for type II diabetes and works by causing blood sugar to leave the body primarily through urine.
The drug was approved by the FDA in 2013 and was predicted to reach blockbuster status, with sales of $596m in the first half of this year.
But the additional FDA warning could reduce its competitiveness as Invokana is already under pressure from Lilly and Boehringer Inglehiem’s rival SGLT2 inhibitor.
The companies’ Jardiance (empaglifozin) was just last month able to claim itself as the first diabetes drug able to lower risk of heart attack, stroke and cardiovascular disease, giving it a further edge over its competition.
However the FDA said in a statement: “We are continuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapaglifozin (Farxia, Xigduo XR) and empagliflozin (Jardiance, Glyxambi, Synjardy) to determine if additional label changes or studies are needed.”
The US regulator urged health care professionals and patients to report side effects involving Invokana or other SGLT2 inhibitors, to its FDA MedWatch programme.