Will Continued Growth for Januvia Translate to Increased Januvia Side Effects?

Whitehouse Station, NJAnyone who may have hoped that a new diabetes drug manufactured by Johnson & Johnson (J&J) could prove a worthy alternative to Merck’s Januvia, and therefore stem Januvia side effects, could wind up somewhat disappointed following speculation that sales of Januvia could continue to grow, even in the face of competition from J&J.

With a recommendation for approval of J&J’s Invokana (canagliflozin) by an advisory panel of the US Food and Drug Administration (FDA), it was hoped that the selective sodium glucose co-transporter 2 (SGLT2) inhibitor could prove a worthy alternative to the Januvia diabetes drug, given concern for Januvia pancreatitis and other adverse events.

But not so fast. According to Business Monitor Online (2/1/13), even with the sunny skies of approval, there lurks a dark cloud of concern with regard to the incoming Invokana and the potential for impact on the heart. In fact, according to Business Monitor Online, FDA expert panelists debating the merits of bringing Invokana to market were concerned about the safety profile of the drug as it relates to patients who are renal impaired or those carrying a risk for cardiovascular disease.

“It is likely that [Invokana] will receive FDA warning labels and the agency will undoubtedly recommend patients with heart or kidney problems to avoid the drug.”

This, according to Business Monitor Online, will likely hinder the growth of Invokana in the short term. The greater issue for Januvia patients however - especially those concerned with the possibility of Januvia cancer and other adverse reactions - is that Januvia is expected to continue growing, in spite of increased competition. “Moreover, we believe Merck’s Januvia will continue to post year-on-year growth, having clinched sales of US $3.3 [billion] in 2011,” the report said.

It’s interesting to note that a blessing for approval of Invokana by the FDA advisory panel comes about a year after the FDA issued a warning letter to Januvia manufacturer Merck, with regard to not fulfilling a post-marketing requirement for a three-month pancreatic safety study. The letter was issued by the FDA’s Office of Scientific Investigations, on February 17 of last year. While there is little “new” in the Januvia news hopper of late, troubling observations remain in association with Januvia pancreatitis. To wit, Januvia has not been studied in patients with a history of pancreatitis, and thus it is not known whether patients with a history of pancreatitis are at increased risk of developing Januvia pancreatitis.

In the same vein, there have been post-marketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking Januvia. There have also been post-marketing reports of worsening renal function (kidney), including acute renal failure, sometimes requiring dialysis. This, according to a statement by Merck released through Targeted News Service a year ago (2/28/12).

Thus, while J&J’s new diabetes drug Invokana appears to afford improved management of glucose levels for diabetics over Januvia, the potential for restriction to patients with renal function and/or cardiovascular issues (which continues to grow within an aging population) suggests continued growth for the Januvia medication.

Provided the foregoing proves realistic, could it result in more reports of Januvia and pancreatitis, or other adverse events? Time will tell.