Roche arthritis treatment given green light by EU advisory group

Roche is one step closer to being allowed to market its RoActemra rheumatoid arthritis (RA) treatment in Europe after the Committee for Medicinal Products for Human Use (CHMP) recommended its approval.

The group advises the European Medicines Agency and has issued this positive assessment of the subcutaneous formulation following the results of phase III SUMMACTA and BREVACTA studies, which demonstrated its efficacy and tolerability.

According to the CHMP, RoActemra should be approved for treatment of patients with moderate to severe RA, who have not responded to or have become intolerant to previous therapy with disease modifying anti-rheumatic drugs or tumour necrosis factor inhibitors.

An intravenous sister product is already available, but it is hoped RoActemra – which is delivered under the skin through a pre-filled pen and syringe – will offer patients the option of administering the treatment in their own homes.

If the drug is approved by the EMA, it will be the first IL-6 biologic available in both subcutaneous and intravenous administration, therefore providing potential combination therapy.