Results from the CANVAS and CANVAS-R study investigating cardiovascular risks with the blockbuster type 2 diabetes drug Invokana are expected later this year. Invokana manufacturer Johnson & Johnson (J&J) and its subsidiary Janssen Pharmaceuticals are hoping for label-changing results like that of rival Jardiance, which showed the drug reduced the risk of cardiovascular death in diabetics with heart disease. But some analysts are skeptical.
“While pure speculation on our part, it’s possible that J&J has seen more of the CANVAS/CANVAS-R data since the Q3 call and feels less confident in the outlook,” Wells Fargo Securities noted following the drug company’s fourth-quarter call during which Chief Executive Alex Gorsky seemed to downplay the study’s results. Gorsky would not say when the study’s results would be revealed, only that there were “very important, very promising trials coming up in Invokana this year,” a contrast to the previous quarter when Janssen’s Research & Development head William Hait said that he was confident that the Invokana data would mirror that seen in the Emp-Reg Outcome study of Jardiance.
The CANVAS program is expected to be completed in early 2017, after which J&J is expected to evaluate the studies in one analysis. When that data will be made public is yet to be revealed. Some speculate that the company will present it at the American Diabetes Association meeting in San Diego in June.
It’s been a rocky road for the top selling diabetes drug, the first in a class known as SGLT2 inhibitors. Since Invokana entered the market in 2013, the FDA has strengthened warnings or added new earnings to many of the drugs – serious urinary tract infections, bone mineral density loss, bone fractures and ketoacidosis for all SGLT2 inhibitors; and acute kidney injury for Invokana, Invokamet, Farxiga and Xigduo XR. The FDA is also investigating whether Invokana and Invokamet increase the risk of lower limb amputations.
Source: Seeking Alpha