FDA Approves Expanded Indication for Actemra in Rheumatoid Arthritis

Genentech, Inc, a member of the Roche Group, today announced that the FDA has expanded the approved indication for Actemra (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Actemra can be used both alone as a single-agent therapy and in combination with methotrexate (MTX) or other DMARDs. The expanded indication further supports the safety and efficacy profile of Actemra.

"People with moderately to severely active RA can suffer irreversible joint damage that may be prevented by earlier treatment with a biologic medicine such as Actemra," said Hal Barron, MD, chief medical officer and head, Global Product Development. "We're pleased that these patients will now have Actemra as an additional option."

The expanded indication is based on efficacy and safety data from the Phase III clinical trials which were previously available, safety data collected from the post-marketing experience with Actemra since approval in 2010, as well as data from other clinical studies, including those evaluating Actemra in a real-world setting.

About Previous Actemra Efficacy Trials in DMARD-IR Patients

• OPTION (TOcilizumab Pivotal Trial in methotrexate Inadequate respONders) trial: 59% and 48%of patients who received Actemra 8 mg/kg and 4 mg/kg plus MTX, respectively, achieved ACR20 at Week 24, compared with 27% of patients who received placebo plus MTX
• TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) trial: 61% of patients who received Actemra 8 mg/kg plus DMARD(s) achieved ACR20 at Week 24, compared with 25% of patients treated with DMARDs plus placebo
• LITHE (TociLIzumab safety and THE prevention of structural joint damage) trial: 56% and 51% of patients who received Actemra 8 mg/kg or 4 mg/kg plus MTX, respectively, achieved ACR20 at Week 24 compared with 27% of patients who received placebo plus MTX. In addition, Actemra 4 mg/kg slowed (less than 75% inhibition compared to the control group) and Actemra 8 mg/kg inhibited (at least 75 percent inhibition compared to the control group) the progression of structural damage compared to placebo plus MTX at week 52, as measured by change in total Sharp-Genant score.

ACR improvement criteria is a standard assessment developed by the American College of Rheumatology to measure the signs and symptoms of RA. ACR20, ACR50, ACR70 represent the percentage of reduction (20 percent, 50 percent, 70 percent) in certain RA signs and symptoms, such as the number of tender and swollen joints, pain, patients' and physicians' global assessments and certain laboratory markers. The Genant-modified Sharp score focuses on 14 specific sites for evidence of bone erosion and 13 sites for narrowing of the joint space, both key measures of ongoing structural damage to the joints. A high score or an increase in the score over time represents a greater extent of damage.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an autoimmune disease estimated to affect up to 70 million people worldwide, including children. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.

About Actemra (tocilizumab)

Actemra is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). The extensive Actemra clinical development program included 5 Phase III clinical studies and enrolled more than 4000 people with RA in 41 countries, including the United States. In addition, Actemra is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older.

SOURCE: Genentech