Novo Nordisk's ($NVO) diabetes drug Victoza is one of its best-selling drugs, bringing in more than $2 billion last year. But it has been dogged by concerns, and critics, that it raises the risk of pancreatitis. Despite it and other similar drugs being cleared by reviews by both the FDA and EU regulators this year, some keep pushing the FDA to consider pulling it off the market.
As Regulatory Focus points out, the FDA in March denied a petition to pull the Type 2 diabetes drug from the market filed in 2012 by consumer advocacy group Public Citizen. The FDA said labeling changes to the drug had addressed their concerns. But rather than accept the denial, the group did a review of FDA adverse event reports and whipped together a new study that it posted yesterday and pointed out in a letter to the agency, again asking it to pull the drug from the market.
The letter says its review of FDA data found that there were 278 cases of acute pancreatitis reported to the FDA between February 2010 and December 2011 in which the drug was the primary suspect, and that 60% of those resulted in hospitalizations and two in death. It said its own review found that the drug was the probable cause in 51 cases. "These results suggest a causal link between liraglutide and the occurrence of acute pancreatitis," it wrote in its report. It said other studies also found links, studies not considered by the FDA when it turned down Public Citizen's first request for a ban.
What the FDA will do is hard to say. It and European Medicines Agency jointly launched a safety review last year after newly released studies flagged pancreatic problems in patients using incretin mimetics. Besides Januvia and Victoza, the group includes AstraZeneca's ($AZN) Onglyza, Takeda's Nesina, and Eli Lilly ($LLY) and Boehringer Ingelheim's Tradjenta, which are DPP-4 inhibitors. It also comprises AstraZeneca's Byetta and Bydureon, both GLP-1 drugs. In February, the regulators jointly announced in a study in the The New England Journal of Medicine that suggestions the drugs could cause pancreatic disease are "inconsistent with current data." But they also said the issue wasn't dead. They acknowledged they "have not reached a final conclusion" and that they will continue to investigate.
The latest attack comes as the FDA is considering whether Novo Nordisk should be allowed to broaden its sales of liraglutide as a weight-loss drug. While analysts projections vary widely on what that indication could mean for sales, some have put it as high as another $1 billion.