The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Arzerra® (ofatumumab, Glaxo Group Ltd) 20mg/ml, concentrate for solution for infusion intended for the treatment of chronic lymphocytic leukaemia (CLL). Arzerra was designated as an orphan medicinal product on 7 November 2008.

The approved indication is given in the link below as:
“Treatment of CLL in patients refractory to fludarabine and alemtuzumab”.