FDA awards supplemental approval to support efficacy of ACTEMRA in treating RA

Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the United States (U.S.) Food and Drug Administration (FDA) has extended the ACTEMRA^® (tocilizumab, RoACTEMRA in the European Union) label to include inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis (RA), when given in combination with methotrexate (MTX). The supplemental approval comes one year after initial U.S. approval and supports the efficacy of ACTEMRA in treating RA.

“For those who are faced with the daily challenges of RA, inhibition and slowing of joint damage is imperative if patients are to truly achieve their treatment goals.”

RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications. Joint damage often begins early in the disease and can lead to permanent disability; therefore, inhibiting structural damage to patients' joints is a critical measure of the effectiveness of an RA treatment.

The new U.S. license extension was based on positive data from the Phase III LITHE trial which demonstrated that patients receiving either dose of ACTEMRA (4 mg/kg or 8 mg/kg) in combination with MTX had significantly less damage to their joints at one year, compared to patients in the control group. The outcome was determined by X-rays which measured the progression of bone erosions and narrowing of joint spaces over time.

"This FDA approval further supports the efficacy of Actemra and follows a similar approval in the EU," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "For those who are faced with the daily challenges of RA, inhibition and slowing of joint damage is imperative if patients are to truly achieve their treatment goals."

The LITHE study also showed that patients who received either dose of ACTEMRA (4 mg/kg or 8 mg/kg) plus MTX showed significant improvement in physical function, compared with patients who received MTX plus placebo at week 52. More patients treated with ACTEMRA also achieved major clinical response, defined as achieving an ACR 70 response for a continuous 24-week period, compared to MTX plus placebo. No new or unexpected safety signals were identified with ACTEMRA, and safety was consistent with previous studies.

ACTEMRA was approved by the FDA on January 8, 2010 as the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody to treat moderately to severe active RA in adult patients after an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. It can be used as monotherapy or in combination with MTX or other disease modifying anti-rheumatic drugs (DMARDS).

The treatment is also approved for use in the European Union and a growing number of other countries including Japan, Mexico, India, Brazil, Switzerland and Australia.

SOURCE Genentech, Inc.