Roche submits FDA application for Actemra approval

Roche has sought approval from the US Food and Drug Administration for the use of Actemra in patients with moderate to severe rheumatoid arthritis (RA).

The company submitted a biologics licence application (BLA) for the indication of Actemra (tocilizumab) in reducing signs and symptoms in adults with RA.

William M Burns, chief executive officer of the pharmaceuticals division at Roche, described the filing as an “important milestone”.

“It brings us another step closer to making this therapy available to the millions of patients in the United States who suffer from pain and debilitating effects of rheumatoid arthritis,” he asserted.

The BLA submission came off the back of five international Phase III studies demonstrating Actemra to reduce the signs and symptoms of rheumatoid arthritis, as measured by ACR and disease activity score remission rates.

Actemra, combined with disease modifying anti-rheumatic drugs (DMARDs) such as such as methotrexate, was shown to be more effective than with DMARD therapies alone.

Roche is now expected to file a Marketing Authorisation Application for Actemra to the European Medicines Agency in December.

Earlier this month, Roche announced that the FDA approved Mircera for the treatment of anaemia associated with chronic renal failure in adult patients both on and off dialysis treatment.