Monday, October 15, 2012

USFDA Approves expanded indication for Actemra (Tocilizumab)

USFDA has approved  Roche / Chugai's Actemera  for use in moderate to severe adult Rheumatoid Arthritis patients with inadequate response to one or more disease modifying anti rheumatic drugs (DMARDs).  Actemra can be used both as monotherapy and in combination with methotrexate or other DMARDs.



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:
o 59 percent and 48 percent of patients who received ACTEMRA 8 mg/kg and 4 mg/kg plus MTX, respectively, achieved ACR20 at Week 24, compared with 27 percent of patients who received placebo plus MTX
• TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) trial:
o 61 percent of patients who received ACTEMRA 8mg/kg plus DMARD(s) achieved ACR20 at Week 24, compared with 25 percent of patients treated with DMARDs plus placebo
• LITHE (TociLIzumab Safety and THE Prevention of Structural Joint Damage) trial:
o 56 percent and 51 percent of patients who received ACTEMRA 8 mg/kg or 4 mg/kg plus MTX, respectively, achieved ACR20 at Week 24 compared with 27 percent of patients who received placebo plus MTX. In addition, ACTEMRA 4mg/kg slowed (less than 75 percent 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 + MTX at week 52, as measured by change in total Sharp-Genant score.