Victoza: EMA Moving Forward While FDA Idles Over Victoza and Cancer

Washington, DCWhile cautious concern still exists with regard to Victoza side effects, the European Medicines Agency (EMA) has begun the process of actually allowing for expanded use of Victoza in the areas of the world governed by the EMA.

Specifically, the EMA is considering a label expansion for Victoza (liraglutide) that will allow physicians to prescribe GLP-1 receptor agonists such as Victoza in combination with a basal insulin such as Tresiba (insulin degludec). Driving the expanded use, according to Business Monitor Online (3/24/14), is the Committee for Medicinal Products for Human Use (CHMP), an entity that exists within the EMA framework.

The EMA’s North American counterpart, the US Food and Drug Administration (FDA), thus far has shown no desire to expand the usages of Victoza beyond that for which the type 2 diabetes drug is already indicated. However, the posturing of regulators in Europe is hardly surprising given a joint statement published by both regulators in which they could find no causal link between Victoza and cancer.

Such Victoza side effects have long been a concern for organizations such as Public Citizen, the consumer advocate that lobbied the FDA to pull Victoza from the market. Public Citizen was concerned about the potential for pancreatitis, kidney failure, thyroid cancer and serious allergic reactions.

The allegations sufficiently concerned both the FDA and EMA to place Victoza and other drugs in its class under a microscope - especially given the conclusions of some researchers that appeared to support such cautions as Victoza Cancer.

In the end, however, the FDA and EMA jointly concluded that studies have largely been inconclusive, and thus a causal association to Victoza Pancreatic Cancer and other adverse reactions did not sufficiently exist to warrant further caution.

“Both agencies agree that assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer, as expressed recently in the scientific literature and in the media, are inconsistent with the current data,” the agencies said in a joint statement appearing in The New England Journal of Medicine (NEJM 2/27/14).

At the same time, however, the agencies indicated they had yet to make a final determination about the potential link regarding Victoza Thyroid Cancer and other adverse reactions.

And then they said this:

“Although the totality of the data that have been reviewed provides reassurance, pancreatitis will continue to be considered a risk associated with these drugs until more data are available,” they said.

Thus it appears odd that the EMA is allowing for an expanded use of Victoza, while agreeing with the FDA that a link between Victoza and cancer is still possible but just hasn’t been proven.

So far, the FDA appears to be doing what it does best: wait and see. For its part, Public Citizen’s position on Victoza remains unchanged. They note that two of the FDA’s own reviewers advised against the approval of Victoza in the first place.

Consolidated lawsuits carry on, nonetheless. As for Victoza cancer risk, the horse may still be in the barn, but the stallion is pawing at the door - and it may just be a matter of time.

The Victoza lawsuit (Multidistrict Litigation) is In re: Incretin Mimetics Products Liability Litigation, Case No. 3:13-md-02452, in the US District Court for the Southern District of California.