GlaxoSmithKline drug Arzerra receives positive EU opinion

GlaxoSmithKline announced this week that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Arzerra (ofatumumab) – its refractory chronic lymphocytic leukaemia (CLL) therapy.

The treatment is a novel human monoclonal that focuses on a unique part of the CD20 molecule, which is a key target in CLL therapy.

Conditional marketing authorisation for the compound has been suggested by the CHMP for the drug’s treatment of patients with CLL who are refractory to exisiting therapies fludarabine and alemtuzumab.

Those with CLL who have not responded to treatment – or who have disease progression within six months to the latest treatment – are termed as refractory.

As part of the terms of the CHMP’s conditional marketing authorisation for ofatumumab, GlaxoSmithKline will now be required to provide further data on the drug.

In other GlaxoSmithKline news, the company revealed last week that it will make its malaria research database, which contains details of 13,500 molecules, available to other organisations.