United States-based Biogen and United States-based AbbVie are withdrawing their multiple sclerosis drug, Zinbryta, from global market, it was reported yesterday.

The company has taken this step after reports of eight cases of serious brain inflammation. The European Medicines Agency (EMA) has commenced an Article 20 referral procedure after reports of inflammatory encephalitis and meningoencephalitis. Seven cases of serious inflammatory brain disorders including encephalitis and meningoencephalitis have been reported in Germany, while the other case has come from Spain.

The EMA's Pharmacovigilance Risk Assessment Committee will undertake the initial review of Zinbryta and come up with a set of recommendations. PRAC is the regulator's committee that is responsible for assessing safety issues for human medicines.

Zinbryta, a monthly once, self-administered, subcutaneous injection, gained EU and US approvals in 2016 for the treatment of adult patients with relapsing forms of multiple sclerosis.