Results from this Analysis were Published in eClinicalMedicine
JERSEY CITY, N.J. August 15, 2022 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of a paper entitled, “Intravenous edaravone treatment in ALS and survival: an exploratory, retrospective, administrative claims analysis,” in eClinicalMedicine, part of The Lancet Discovery Science. Results from the analysis suggest that continued treatment with RADICAVA® (edaravone) in people with amyotrophic lateral sclerosis (ALS) was associated with prolonged survival compared to those not treated with the drug in a real-world setting based on U.S. administrative claims data.
“Real-world data may bridge gaps in knowledge that exist between clinical trials and everyday medical practice,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. “While a randomized clinical trial is required to support the findings from this analysis, these data provide important insights from a real-life setting and deepen our understanding of RADICAVA’s role in the treatment of ALS.”
The retrospective, observational study utilized Optum’s Clinformatics® Data Mart (CDM), a real-world de-identified database of administrative health claims across the U.S. for members with commercial or Medicare Advantage health plans, to assess overall survival among commercially insured ALS patients (≥18 years) who were treated continuously with RADICAVA, compared to a control group of patients not prescribed RADICAVA. The median treatment duration with RADICAVA was 8.6 months. Implementing 1:1 propensity score matching, the analysis compared 318 non-RADICAVA-treated control patients with 318 patients who initiated RADICAVA treatment between August 8, 2017, and March 31, 2020.
“ALS has been a clinically challenging disease to evaluate due to its heterogeneity and average life expectancy,” said Benjamin Rix Brooks, M.D., a longtime leader in ALS research and lead author of the study. “The results from this analysis showed that, for this specific group, treatment with RADICAVA led to the observation of a lower number of deaths and risk of death as well as longer overall survival estimates compared to those not on therapy. These real-world findings are encouraging and will help inform future research for this devastating disease.”
Results from the analysis showed:
- Treatment with RADICAVA was associated with a six-month longer median survival compared with the non-RADICAVA-treated patients. The median treatment duration with RADICAVA was 8.6 months.
- Median survival was 29.5 months (95% CI, 25.4-35.9) for the RADICAVA-treated patients and 23.5 months (95% CI, 20.0-28.0) for the non-RADICAVA-treated patients.
- The risk of death during the study was 27% lower for the RADICAVA-treated patients than for non-RADICAVA-treated patients (hazard ratio [HR], 0.73; 95% CI, 0.59–0.91).
- Between August 8, 2017, and March 31, 2021, 155 all-cause deaths (48.7%) were reported among RADICAVA-treated patients vs. 196 (61.6%) among the non-RADICAVA-treated patients.
It is important to note that results from this study are not generalizable and cannot be used to determine definitive conclusions about the effects of treatment. This study used real-world data, it was not randomized, it was observational, exploratory and retrospective in nature, and may be subject to unknown bias and confounding factors. Understanding the utility and limitations of real-world data is critical to proper application of insights.1
This analysis was funded and conducted by MTPA.
About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA is administered in 28-day cycles by IV infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.2
Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and Mitsubishi Tanabe Pharma Development America, Inc (MTDA), commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, RADICAVA was approved for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), China (July 2019), Indonesia (July 2020), Thailand (April 2021) and Malaysia (December 2021). To date, in the U.S., RADICAVA has been used to treat over 6,500 patients, with nearly one-million days of therapy, and has been prescribed by more than 1,600 HCPs.3
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
Sulfite Allergic Reactions
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
Adverse Reactions
The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Pregnancy
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
For more information, including full Prescribing Information, please visit www.RADICAVA.com.
About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC to commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.
About Mitsubishi Tanabe Pharma Development America, Inc.
The U.S. headquarters of Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) is located in Jersey City, New Jersey. MTDA is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s 100 percent-owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. For more information, please visit https://mt-pharma-development-america.com/.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of the Mitsubishi Chemical Group, is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. The Mitsubishi Chemical Group has positioned health care as its strategic focus in its management policy, “Forging the future”. MTPC sets the MISSION of “Creating hope for all facing illness”. To that end, MTPC is prioritizing work on “precision medicine” to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. In addition, MTPC is working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/.
Media inquiries:
Media_MTPA@mt-pharma-us.com
- U.S. Food and Drug Administration. Framework for FDA’s Real-World Evidence Program. Accessed March 2022. https://www.fda.gov/media/120060/download.
- RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
- Data on file. Mitsubishi Tanabe Pharma America, Inc.