EMA Decision on Januvia Class Cuts the FDA Some Slack

Washington, DCThe oft-maligned US Food and Drug Administration (FDA), currently in the throes of monitoring Januvia side effects with regard to the potential for pancreatic cancer, has been cut a bit of slack thanks to the European Medicines Agency (EMA). The European equivalent to the FDA is often ahead of the FDA in taking positions with drugs thought to have the potential to harm, and taking a harder stance in the process.

However this time, the EMA has come to the same conclusion as the FDA with regard to Januvia and cancer. While various studies have raised that possibility, The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that available data is insufficient to take any conclusive stance on GLP-1-based diabetes therapies, a class into which Januvia falls.

The EMA has decided, instead, to tread water until the results of two large, independent studies funded by the European Commission are available, beginning with the first data sets in spring 2014.

That’s basically the position taken by the FDA, which has acknowledged the publication of various studies suggesting a link between Januvia and cancer but reluctant to make any labeling changes or put other restrictions into force beyond what it already has mandated until more conclusive evidence is forthcoming. It remains a common position for the FDA: to place a product under review, but take no conclusive action unless absolutely necessary.

In so doing, the FDA has often been criticized for inaction. And on the Januvia pancreatic cancer file, the nation’s drug watchdog appears to have been embarrassed into the issuance of a safety alert with regard to Januvia and cancer after a former FDA reviewer challenged the agency about the lack of safety warnings in spite of the release of a study published in the Journal of the American Medical Association (JAMA) with regard to a signal for pancreatic cancer.

As revealed by LawyersandSettlements.com writer Jane Mundy, the FDA released a safety alert for Januvia cancer (pancreatitis) soon after.

Cancer of the pancreas is one of the most serious and most aggressive forms of cancer.

In the past, the EMA has taken more pointed stances on drugs suspected of being unsafe, whereas the FDA has maintained a “wait-and-see” approach. And so earlier this year, when the EMA decided to review GLP-1 diabetes drugs - including Januvia (sitagliptin) - following the publication of a study that suggested an increased risk for Januvia pancreatitis and pancreatic cancer linked to other drugs in the same class as Januvia, all eyes have been on the EMA to see what the agency concluded, and how that would compare to the FDA’s position.

The EMA acknowledged that a small number of cases of pancreatitis have been reported in clinical trials, together with additional cases of pancreatitis revealed by way of “spontaneous reports.” All eyes were on the EMA to see if it would bring the hammer down on Januvia side effects and other drugs in the same class as sitagliptin for the treatment and maintenance of Type 2 diabetes.

In the end, according to a release by the EMA (7/26/13), the European drug watchdog is taking a page from the FDA and taking concerns about Januvia pancreatitis and adverse events associated with other drugs in the GLP-1 class under advisement, until more conclusive information is available starting next spring.

For now, it takes the heat off the FDA, although not completely, given the number of plaintiffs who have been in contact with a Januvia lawyer with regard to a Januvia lawsuit. As of last month, there were more than 50 lawsuits filed in federal court, with consideration being given to having them consolidated under multidistrict litigation (In Re: Incretins Products Liability, Sales and Marketing Litigation, MDL 2452, United States Judicial Panel on Multidistrict Litigation).

In the meantime, the Januvia and pancreatitis watch continues.