Growing competition and increased side effect concerns may be weighing on Invokana, the Type 2 diabetes medication marketed by Johnson & Johnson’s Janssen Pharmaceuticals unit.
According to Johnson & Johnson’s latest earnings report, fourth quarter 2017 sales of the medication missed analysts’ expectations, dropping 29%, to $262 million.
A report from Reuters notes that Invokana is already facing competitive pressure from Jardiance. The U.S. Food & Drug Administration’s (FDA) recent approval of Merck and Pfizer’s Steglatro will only add to that pressure.
Invokana (canagliflozin) was approved by the FDA in 2013, and was the first of a new class of Type 2 diabetes medications called SGLT2 inhibitors to hit the market. These drugs work by preventing the absorption of glucose by the kidneys.
Since its launch, Invokana and other SGLT2 inhibitors have been embroiled in a number of safety controversies.
For example, early results from clinical trials suggested that patients who began taking canagliflozin faced an increased risk of cardiovascular complications during the first 30 days of treatment.
In September 2015, the labels for Invokana and Invokamet were updated to note a possible association with an increased risk for bone fractures and decreased bone density.
In December 2015, the FDA announced that the labels for all drugs in the SGLT2 inhibitor class would be updated to include information regarding the risk of a potentially life-threatening condition called diabetic ketoacidosis, which occurs when toxic acids called ketones accumulate in the blood. If not recognized and treated quickly, diabetic ketoacidosis can progress to diabetic coma and even death.
The prescribing information for several SGLT2 inhibitors, including Invokana, Invokamet, a sister medication consisting of canagliflozin and metformin, was updated yet again in 2016, after the medications were linked to more than 100 reports of acute kidney injury.
Aa new Black Box Warning – the strongest safety warning possible – was added to the labels for Invokana and Invokamet last May, after clinical trial results suggested that canagliflozin was associated with an increased risk of leg and foot amputations.
Well over 900 Invokana lawsuits are currently pending in the U.S. District Court, District of New Jersey, where all federally-filed claims involving the side effects allegedly associated with canagliflozin have been centralized for pretrial proceedings. Additional cases are pending in Pennsylvania, California and New Jersey state courts.
Among other things, plaintiffs claim that Johnson & Johnson and Janssen were aware that canagliflozin could cause potentially life-threatening side effects and complications, but failed to provide doctors and patients with adequate warnings of these risks.
“Defendants also, through their marketing materials, misrepresented and exaggerated the effectiveness of INVOKANA, both as to its ability to lower glucose, and its benefit for non-surrogate measures of health, such as reducing adverse cardiovascular outcomes,” the complaints state.