Johnson & Johnson and its subsidiary Janssen Pharmaceuticals were relieved to unveil promising cardiovascular outcomes from a study involving their type 2 diabetes medication Invokana at the American Diabetes Conference last month.
But while the data shows that patients taking the drug were less likely to suffer from a heart attack or stroke, the numbers were not as impressive as the ones laid out previously by Eli Lilly and Co. and Boehinger Ingelheim for their diabetes treatment Jardiance, BioPharma Dive reports. Even more upsetting is that Invokana was slapped with new warnings in recent weeks, this time for an increased risk of lower limb amputations.
Despite the news, Jardiance sales have not caught up to Invokana or other diabetes drugs in the SGLT2 inhibitor class. One reason may be because physicians see the cardiovascular benefits posted by Jardiance as being a classwide effect. However, Invokana’s data, while showing some cardiovascular benefit, has proven that Jardiance is best-in-class.
Couple that with the laundry list of new or strengthened warnings slapped on many drugs in the class, all of which have hit Invokana and Invokamet, and some of which do not name Jardiance.
For example, in May 2015, the Food and Drug Administration (FDA) issued new warnings on all SGLT2 inhibitors for an increased risk of ketoacidosis and serious urinary tract infections. In September 2015, the FDA warned that Invokana and Invokamet were linked to an increased risk of bone fractures and decreases in bone mineral density. In June 2016, the FDA ordered stronger warnings on Invokana, Invokamet, Farxiga and Xigduo regarding acute kidney injury risks. And last month, the FDA ordered the amputation warning for Invokana and Invokamet.
In December 2016, the U.S. Judiciary Panel on Multidistrict Litigation consolidated dozens of lawsuits in New Jersey federal court alleging Johnson & Johnson and Janssen failed to warn consumers about serious health risks with Invokana and Invokamet.