Allergan has been working hard to buoy IBS-D med Viberzi through a series of marketing efforts and tech partnerships. But now, a safety hurdle could get in the way.
The FDA has warned (PDF) that patients without a gallbladder shouldn’t use the med after an agency review found an increased risk for those patients of developing serious pancreatitis that could result in hospitalization or even death.
In fact, hospitalizations and deaths from pancreatitis have already been reported in patients without gallbladders who were taking Allergan’s product, the FDA said. Regulators recommended patients in that pool “stop taking Viberzi right away.”
“We are working with the Viberzi manufacturer, Allergan, to address these safety concerns,” the FDA said in its announcement.
Allergan did not immediately return a request for comment.
It’s a setback for the Dublin drugmaker, which has been pushing hard to expand use of the med since winning a May 2015 approval on the same day as Valeant’s IBS-D contender, Xifaxan.
To do so, it’s joined forces with a world champion paratriathlete to encourage patients to speak with physicians sooner, inked a pact with a population health management specialist to develop monitoring tools for doctors, and rolled out a set of online resources for patients to help identify and manage symptoms.
Still, despite the efforts—and Valeant’s turnover issues—it’s Xifaxan that has the revenue lead. Viberzi drummed up just $94.3 million in 2016, while Xifaxan—which is also approved to treat hepatic encephalopathy—recorded $251 million in the fourth quarter alone.