Analysis of Post-Marketing Safety Data Shows Consistent Findings with Safety Profile Reported in Clinical Trials of Edaravone
JERSEY CITY, N.J., June 29, 2022 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced findings from an analysis of post-marketing safety data evaluating RADICAVA® (edaravone) in a real-world setting during the first three years of availability in the United States (U.S.) for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA maintained a similar safety profile as seen in clinical trials, with no new safety signals or inconsistencies with the clinical trials identified over the treatment period. Study findings were published in a paper entitled, “Analysis of the U.S. Safety Data for Edaravone (Radicava®) From the Third Year After Launch,” in Drugs in R&D.
“We are pleased to share three-year findings from the post-marketing safety analysis of RADICAVA that reinforce its well-established safety profile as reported in clinical trials,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “We remain focused on learning as much as possible about the use of RADICAVA in a real-world setting, and these data signify an additional milestone toward achieving that goal.”
RADICAVA was approved by the U.S. Food and Drug Administration (FDA) in May 2017, as an intravenous infusion treatment for ALS. The FDA approval of RADICAVA was supported by multiple trials from its comprehensive clinical development program, including the pivotal, Phase 3 study (MCI186-19) evaluating 137 patients with ALS. The most common adverse reactions that occurred in greater than 10 percent of patients were bruising (contusion), problems walking (gait disturbance) and headache. The current post-marketing analysis provides an update on the safety profile of RADICAVA based on real-world usage data and adverse event (AE) reporting, as identified from a post-marketing safety database between August 8, 2017, through August 7, 2020.
Key findings from the analysis include:
- The most commonly reported AEs were death (not specified), drug ineffective, disease progression, therapeutic response unexpected, fall, asthenia, fatigue, muscular weakness, gait disturbance and dyspnea.
- The most commonly reported serious AEs (SAEs) included death (not specified), pneumonia, disease progression, ALS, fall, dyspnea, respiratory failure, device-related infection, hospitalization and injection site infection.
- Deaths were most commonly attributed to ALS, disease progression, respiratory failure or pneumonia.
- AE mentions of line infections also appear to be lower than the rates of line infection from central venous catheter placement in home infusion settings in the U.S., Spain, Denmark and Canada.
- Five cases of non-fatal anaphylaxis were reported in this analysis.
“I am encouraged to see that the safety and tolerability profile of RADICAVA observed over the three-year post-marketing treatment period is consistent with reports from the clinical trials,” said Benjamin Rix Brooks, M.D., an ALS specialist and study author. “These data provide HCPs with additional insights they can share with patients when considering treatment with RADICAVA.”
Understanding the utility and limitations of real-world data is critical to proper application of insights.1 The limitations stemming from voluntary reporting and occasional missing information should be considered when interpreting these results. Additional limitations stem from a lack of a control population of patients and the lack of detailed information about most of the AEs that were reported. RADICAVA is contraindicated in patients with a hypersensitivity to edaravone or any of the inactive ingredients in RADICAVA. The post-marketing safety profile should be viewed in the context of the full Prescribing Information. See Important Safety Information below.
The Drugs in R&D publication of this analysis can be found here. This analysis was funded and conducted by MTPA.
About RADICAVA® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017 as a treatment for amyotrophic lateral sclerosis (ALS).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. The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, the IV formulation of edaravone 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).
IMPORTANT SAFETY INFORMATION
Radicava® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in Radicava®. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported. Patients should be monitored carefully for hypersensitivity reactions, and if they occur, discontinue Radicava®, treat per standard of care, and monitor until the condition resolves.
Sulfite Allergic Reactions
Radicava® contains sodium bisulfite, and 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.
Most Common Adverse Reactions
Most common adverse reactions (at least 10% and greater than placebo) are contusion, gait disturbance, and headache.
Based on animal data, Radicava® may cause fetal harm.
No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
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.
Radicava® is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
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 Mitsubishi Chemical Holdings Group (MCHC 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 MCHC 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/.
- U.S. Food and Drug Administration. Framework for FDA’s Real-World Evidence Program. Accessed May 2022. https://www.fda.gov/media/120060/download.
- RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.