Mitsubishi Tanabe Pharma America Announces Analysis of Real-World Survival Data with RADICAVA® (edaravone)

The results of this analysis have been published in eClinicalMedicine

JERSEY CITY, NJ, August 15, 2022 /PRNewswire/ — Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of an article titled, “Intravenous edaravone treatment in ALS and survival: an exploratory, retrospective, administrative Claims analysis,” in eClinicalMedicinepart of The Science of Lancet Discovery. The results of the analysis suggest that continued treatment with RADICAVA® (edaravone) in people with amyotrophic lateral sclerosis (ALS) was associated with prolonged survival compared to those who were not treated with the drug in a real-world setting based on US administrative claims data.

“Real-world data can bridge the knowledge gaps that exist between clinical trials and daily medical practice,” said Gustavo A. Suarez Zambrano, MD, Vice President of Medical Affairs, MTPA. “Although a randomized clinical trial is needed to support the results of this analysis, these data provide important information in a real-world setting and further our understanding of the role of RADICAVA in the treatment of ALS.”

The retrospective observational study used Clinformatics from Optum® Data Mart (CDM), an anonymized real-world database of administrative health claims across the United States for members with commercial health plans or Medicare Advantage, to assess overall survival of commercially insured ALS patients (≥ 18 years) who were continuously treated with RADICAVA, compared to a control group of patients not prescribed RADICAVA. The median duration of treatment with RADICAVA was 8.6 months. Implementing 1:1 propensity score matching, the analysis compared 318 control patients not treated with RADICAVA with 318 patients who started RADICAVA treatment between August 8, 2017and March 31, 2020.

“ALS has been a clinically difficult disease to assess due to its heterogeneity and average life expectancy,” said Benjamin Rix Brooks, MD, a long-time leader in ALS research and lead author of the study. “The results of this analysis showed that, for this specific group, treatment with RADICAVA led to the observation of a lower number of deaths and a lower risk of death as well as longer overall survival estimates. compared to those not on treatment. These real-world results are encouraging and will help inform future research into this devastating disease.”

The results of the analysis showed:

  • Treatment with RADICAVA was associated with a longer median survival of six months compared to patients not treated with RADICAVA. The median duration of treatment with RADICAVA was 8.6 months.
    • The median survival was 29.5 months (95% CI, 25.4-35.9) for patients treated with RADICAVA and 23.5 months (95% CI, 20.0-28.0) for patients not treated with RADICAVA.
  • The risk of death during the study was 27% lower for patients treated with RADICAVA than for patients not treated with RADICAVA (relative risk [HR], 0.73; 95% CI, 0.59 to 0.91).
  • Between August 8, 2017and March 31, 2021155 deaths from all causes (48.7%) were reported in patients treated with RADICAVA compared to 196 (61.6%) in patients not treated with RADICAVA.

It is important to note that the results of this study are not generalizable and cannot be used to draw firm conclusions about treatment effects. This study used real-world data, was not randomized, was observational, exploratory, and retrospective in nature, and may be subject to unknown biases and confounders. Understanding the usefulness and limitations of real-world data is essential to the successful application of information.1

This analysis was funded and carried out by the MTPA.

About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone)

The United States Food and Drug Administration (FDA) has approved RADICAVA® (edaravone) on May 5, 2017and 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, treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All subsequent cycles are infused daily for 10 days over 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 over a 14-day period followed by a 14-day drug-free period. RADICAVA ORS should be taken in the morning after an overnight fast. Patients should not eat or drink (except water) for 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), marketed in the United States by Mitsubishi Tanabe Pharma America, Inc (MTPA). The MTPC group companies began their ALS research 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 then granted in Canada (October 2018), Swiss (January 2019), China (July 2019), Indonesia (July 2020), Thailand (April 2021) and Malaysia (December 2021). To date, in the United States, RADICAVA has been used to treat more than 6,500 patients, with nearly one million treatment days, and has been prescribed by more than 1,600 healthcare professionals.3

IMPORTANT SAFETY INFORMATION

Hypersensitivity reactions
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or to any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals and erythema multiforme) and cases of anaphylaxis (hives, decreased blood pressure and dyspnoea) have occurred with RADICAVA.

Patients should be carefully monitored for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat according to standard of care, and monitor until the condition resolves.

Allergic reactions to sulphites
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible individuals. The overall prevalence of sulphite sensitivity in the general population is unknown, but occurs more frequently in people with asthma.

Side effects
The most commonly reported adverse reactions (≥10%) in patients treated with RADICAVA were bruising (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 can cause fetal harm.

To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You can also report suspected side effects 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 complete prescribing information, please visit www.RADICAVA.com.

About Mitsubishi Tanabe Pharma America, Inc.

Situated at Jersey City, New JerseyMitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), a wholly owned US holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC to market pharmaceutical products approved in North America. For more information, please visit www.mt-pharma-america.com or follow us on TwitterFacebook and LinkedIn.

About Mitsubishi Tanabe Pharma Development America, Inc.

The U.S. headquarters of Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) is located at Jersey City, New Jersey. MTDA is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s wholly-owned US 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 pharmaceutical arm of 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, Osakabirthplace of from Japan pharmaceutical industry. The Mitsubishi Chemical Group has positioned healthcare as its strategic axis in its management policy, “Forging the future”. MTPC’s MISSION is to “Create hope for all those who face the disease”. To this end, the MTPC is prioritizing work on “precision medicine” to deliver medicines with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on areas pathologies of the central nervous system and of immuno-inflammation. In addition, MTPC works to develop “pill-based solutions” to address specific patient concerns based on therapeutic medicine, including disease prevention, pre-symptomatic disease care, prevention of aggravation and the prognosis. For more information, please visit https://www.mt-pharma.co.jp/e/.

Media inquiries:
[email protected]


1 US Food and Drug Administration. Framework for the FDA Real World Evidence Program. Accessed March 2022. https://www.fda.gov/media/120060/download.
2 RADICAVA and RADICAVA ORS prescribing information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
3 Data on file. Mitsubishi Tanabe Pharma America, Inc.

SOURCEMitsubishi Tanabe Pharma America, Inc.