Abbvie and Biogen pull multiple sclerosis drug Zinbryta following urgent EMA safety review

Biogen and Abbvie have announced their intention to voluntarily withdraw their multiple sclerosis therapy Zinbryta (daclizumab) from all global markets following the decision by the European Medicines Agency to launch an urgent review after eight cases of serious inflammatory brain disorders were reported.

Seven of the cases were identified in Germany and one in Spain, and included encephalitis and meningoencephalitis. The pharma pair said in a release detailing the decision that they believed that “characterising the complex and evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated”.

“Biogen believes the voluntary worldwide withdrawal of Zinbryta, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” commented Dr Alfred Sandrock, Executive Vice President and Chief Medical Officer at Biogen. “Biogen and AbbVie continue to prioritise patient safety and the care of multiple sclerosis patients worldwide.”

To this end, the pair said that they will continue to work with regulatory bodies and healthcare providers to ensure an effective withdrawal and support Zinbryta patients.

Zinbryta was approved in the US in 2016, where it is marketed by Abbvie; Biogen handles marketing duties in Europe, Canada and Switzerland. The drug generated $107 million last year for the two companies, and is used in around 3,000 patients across the world today.

Clinical providers on the Consortium of Multiple Sclerosis Centers (CMSC) Board of Governors have reviewed the post-marketing reports to regulatory agencies of adverse events associated with daclizumab use. While it is unfortunate to lose access to a unique drug with proven efficacy, the issue of patient safety is of critical importance in the treatment of multiple sclerosis. It is reassuring to know that this decision will not significantly impact our overall treatment strategies, as multiple other disease modifying treatments remain with favorable risk/benefit profiles.

By Matt Fellows

PharmaFile

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