Label expanded on Roche’s RA drug RoActemra

Roche has received expanded approval for RoActemra in Europe, which the company says further reinforces the drug as an effective treatment for rheumatoid arthritis.

The Swiss major says that the European Commission has extended the indication on RoActemra (tocilizumab) to reduce the rate of progression of joint damage and improve physical function in patients with RA, when given in combination with methotrexate (MTX). The approval was based on two-year data from the Phase III LITHE trial which demonstrated that patients receiving the interleukin-6 receptor-inhibiting monoclonal antibody in combination with MTX had significantly less damage to their joints at two years, compared to those in the control group.

The outcome was determined by x-rays which measured over time the progression of bone erosions and narrowing of joint spaces, Roche said. The data showed that with long-term use, patients with RA treated with the combo suffered 81% less damage to their joints compared to those in the control arm at week 104.

Hal Barron, chief medical officer at Roche, said the extended approval “is great news for patients”. He added that the data had shown not only joint damage inhibition “but consistently demonstrates high signs and symptoms remission rates across a range of RA patient types”.

RoActemra is currently licenced in Europe for use in combination with MTX, to treat adults with moderate to severe RA who responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor antagonists (anti-TNFs). The drug was approved in the USA, where it is sold as Actemra, in January and a filing was made for the new European-approved indication in March.

RoActemra is on the way to becoming a big earner for Roche and first-quarter sales rocketed 236% to 66 million Swiss francs.