Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (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, M.D., 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
Trial in methotrexate
- 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
Tocilizumab in c
ARD therapy) trial:
- 61 percent of patients who received ACTEMRA 8 mg/kg plus DMARD(s) achieved ACR20 at Week 24, compared with 25 percent of patients treated with DMARDs plus placebo
LIzumab safety and
THE prevention of
structural joint damage) trial:
- 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 4 mg/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 plus MTX at week 52, as measured by change in total Sharp-Genant score.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV