- Biogen Inc. and AbbVie Inc. released a joint statement Friday morning revealing the companies were voluntarily withdrawing the multiple sclerosis drug Zinbryta from the market as a result of reports of inflammatory encephalitis and meningoencephalitis.
- The European Medicines Agency issued an Article 20 procedure, which is triggered by safety events related to pharmacovigilance. The procedure could result in a fee for the companies, according to the EMA website. Under Article 20, a Pharmacovigilance Risk Assessment Committee (PRAC) may require further data.
- Zinbryta is currently approved in the EU, U.S., Switzerland, Canada and Australia. It is considered a third-line treatment for relapsing MS and only a small number of patients have ever used the drug due to safety problems.
Zinbryta (daclizumab) was given a boxed warning when it was approved in the U.S. in 2016, relegating it to a third-line therapy after patients failed to control their disease using other treatments. The drug carries warnings for both liver problems and immune system problems which require it only be prescribed under a strict Risk Evaluation and Mitigation Strategy (REMS) program.
While the drug was shown to be effective compared to interferon in clinical trials, safety issues were already cropping up.
After approval, the troubling reports of adverse events related to the administration of the biologic started trickling in. In July 2017, the EMA announced it had provisionally restricted the use of the drug to adult patients who had failed on at least one other disease-modifying therapy (DMT) after a review revealed one report of fatal liver failure and four cases of serious liver injury.
Then, in October 2017, EMA PRAC recommended restricting use of the drug to patients who had an inadequate response to two prior disease-modifying therapies.
Dangers of the medication were also highlighted today in an EMA release, wherein the agency announced it planned to conduct an "urgent review" of the medication following the report of eight cases of serious inflammatory brain disorders (seven in Germany and one in Spain). As a result, Biogen and partner AbbVie voluntarily removed Zinbryta from the market worldwide.
Worldwide revenue from the drug was $107 million in 2017, split on a regional basis between Biogen and AbbVie. Biogen carries ex-U.S. rights, while AbbVie markets the drug here.
This represents only a fraction Biogen's earnings in the MS space; its blockbuster Tecfidera (dimethyl fuarate) brought in $4.2 billion in 2017, while MS stalwart Tysabri (natalizumab) pulled in revenue of $1.9 billion last year. Biogen also makes Avonex, an interferon-based medication for the treatment of MS.
Biogen confirmed to BioPharma Dive there are approximately 3,000 patients (excluding clinical trials) currently treated with Zinbryta worldwide, of which the majority are in the U.S. and Germany. According to the EU regulator, over 8,000 patients to date have received Zinbryta globally.