Multiple sclerosis patients now have fewer treatment options because pharmaceutical manufacturers voluntarily recalled a major MS drug after reports of serious brain inflammation in patients.
AbbVie and Biogen globally recalled daclizumba (Zinbryta) for relapsing MS because “the companies believe that characterizing the complex and evolving benefit/risk profile of Zinbryta will not be possible going forward, given the limited number of patients being treated,” the two companies said in a statement.
They took the action immediately after the European Medicines Agency (EMA) called for an “urgent review” of the drug when eight patients in Europe experienced encephalitis and/or meningoencephalitis.
More than 8,000 patients around the world have received Zinbryta, according to the EMA. It is sold in the European Union, the United States, Switzerland, Canada, and Australia.
“Biogen believes the voluntary worldwide withdrawal of Zinbryta … is in the best interest of patients,” says Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.”
Patients will be impacted by this swift change in the global market for MS drugs, valued at $16.3 billion in 2016. While there are several other available treatments for relapsing MS, Zinbryta has out-performed its counterparts in some studies, leaving patients with fewer treatment options, Kevin W. Chamberlin, PharmD, FASCP, associate clinical professor and assistant department head, Pharmacy Practice, at the University of Connecticut School of Pharmacy in Farmington, CT, tells Drug Topics.
For example, in the DECIDE trial phase 3 trial, which pitted daclizumab versus interferon beta-1a (Avonex), daclizumab performed better, with an annualized relapse rate of 0.22 for daclizumab, versus 0.39 for interferon beta-1a, according to Chamberlin.
“There will still be some patients who may need to switch to other therapies. And, unfortunately, since these patients likely already had an inadequate response to other therapies, their options are reduced,” Chamberlin says.
While daclizumab was approved by the FDA in 2016, the agency warned that the drug could cause "serious or life-threatening liver damage" and "serious immune system disorders.”
“It has had safety concerns, and the treatment guidelines reserve it for use only in patients who have had an inadequate response to two or more other MS medications,” Chamberlin said. “While the removal was prompted by concerns for brain inflammation (encephalitis, meningoencephalitis), there were already concerns for autoimmune reactions for daclizumab.”
As a result of the prior safety concerns, Biogen and AbbVie “have yet to gain much traction for a drug that analysts had felt would be limited to peak sales of $500 million a year,” Endpoint News reports.