RADICAVA ORS® recognized as a MAJOR CONTRIBUTION TO PATIENT CARE by the FDA.1 Request a rep visit.
RADICAVA ORS® (edaravone) is recognized by the FDA as a major contribution to patient care due to its oral route of administration, offering a less burdensome option vs IV administration1
16,400+ people have been treated with RADICAVA® IV or RADICAVA ORS® since 2017 for 2.0 million+ days of therapy3,a,b (see footnote)
RADICAVA® IV and RADICAVA ORS® have been prescribed by 2400+ physicians3,a (see footnote)
RADICAVA ORS® is equivalent to the IV formulation of edaravone2,4
RADICAVA® has been evaluated in
over 2 decades of clinical research, including 4 phase 3 trials5-8
RADICAVA has had 7+ years on the market since it was FDA-approved in 20172,9
Since 1995, RADICAVA® is the only FDA-approved treatment for ALS that met its primary endpoint in a phase 3 clinical study.2,16,20,c (see footnote)
Losing or keeping a single point on the ALSFRS-R can have a significant impact on those living with ALS. That’s why the pivotal phase 3 clinical trial of RADICAVA® was specifically designed to measure change in physical function assessed by the ALSFRS-R.16,21
A report on a survey of 65 members of Northeast ALS Consortium (NEALS) concluded that a treatment is clinically meaningful when it results in 20% to 25% or greater change in the slope of ALSFRS-R reflecting the slowing of functional decline22
33% less changein ALSFRS-R scores from baseline vs placebo at 24 weeks2,16The most common adverse reactions (≥10%) reported in RADICAVA®-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). Fatigue was observed in 7.6% of patients receiving RADICAVA ORS®2
It’s important to note a treatment difference of 2.49-point change from baseline in ALSFRS-R (0.99, 3.98) with P=0.0013 is considered statistically significant.16
To put the results in context, consider what P values suggest and how probable the results are due to chance.24
That means that there is less than 1 in 1000 probability that the results are due to random chance
That means that there is less than 5% probability that the results were due to random chance
No statistical difference
between groups
ALS can progress rapidly.25 Beginning treatment with RADICAVA ORS® can be critical in slowing the loss of physical function.2,16,26
Hear Dr. Appel and Dr. Pattee present data and discuss how RADICAVA ORS® gives patients an administration option that can fit into their life's routines.2
WATCH THE NATIONWIDE WEBCAST VIDEO >
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aBased on RADICAVA ORS® and RADICAVA® IV prescriptions submitted in the US as of August 2024. Not independently verified. Return to content
bDays of therapy based on number of RADICAVA ORS® and RADICAVA® IV cartons sold as of August 2024. Each carton of RADICAVA® IV includes 1 day of therapy. For RADICAVA ORS®, each Starter Kit includes 14 days of therapy, and each Maintenance Kit includes 10 days of therapy. Return to content
cBased on a systematic review of phase II, II/III, and III trials in ALS conducted between 2008 and 2019. Return to content
ALSFRS-R=ALS Functional Rating Scale–Revised; FDA=Food and Drug Administration; IV=intravenous; NG=nasogastric; PEG=percutaneous endoscopic gastrostomy.
References: 1. US Food and Drug Administration. Clinical superiority findings. Accessed April 11, 2024. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinicalsuperiority-findings 2. RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 3. Data on file. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc. 4. Shimizu H, Nishimura Y, Shiide Y, et al. Bioequivalence study of oral suspension and intravenous formulation of edaravone in healthy adult subjects. Clin Pharmacol Drug Dev. 2021;10(10):1188-1197. 5. Yoshino H, Kimura A. Investigation of the therapeutic effects of edaravone, a free radical scavenger, on amyotrophic lateral sclerosis (phase II study). Amyotroph Lateral Scler. 2006;7(4):241-245. 6. ClinicalTrials.gov. Safety study of oral edaravone administered in subjects with ALS. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04165824 7. Brooks BR, Heiman-Patterson T, Wiedau-Pazos M, et al. Edaravone efficacy in amyotrophic lateral sclerosis with reduced forced vital capacity: post-hoc analysis of Study 19 (MCI186-19) [clinical trial NCT01492686]. PLoS One. 2022;17(6):e0258614. 8. Takei K, Watanabe K, Yuki S, et al. Edaravone and its clinical development for amyotrophiclateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):5-10. 9. US Food and Drug Administration. FDA approves oral form for the treatment of adults with amyotrophic lateral sclerosis (ALS). Accessed April 11, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-oral-form-treatment-adults-amyotrophic-lateral-sclerosis-als 10. US Food and Drug Administration. NDA 215446. Accessed May 6, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215446Orig1s000ltr.pdf. 11. ClinicalTrials.gov. Study of oral edaravone in healthy adult males. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04481750 12. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in patients with amyotrophic lateral sclerosis. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04176224 13. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in healthy adult males (drug interaction study and preliminary regimen-finding study). Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04481789 14. ClinicalTrials.gov. Clinical pharmacology study of oral edaravone in amyotrophic lateral sclerosis patients with gastrostomy. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04254913 15. ClinicalTrials.gov. Comparative bioavailability study of oral edaravone administered orally and via a nasogastric tube. Accessed April 11, 2024. https://clinicaltrials.gov/study/NCT04776135 16. Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505-512. 17. Tzeplaeff L, Wilfling S, Requardt M, et al. Current state and future directions in the therapy of ALS. Cells. 2023;12(11):1523. 18. US Food and Drug Administration. Orphan drug designations and approvals. Accessed May 15, 2024. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=478215 19. Takei K, Watanabe K, Yuki S, et al. Edaravone and its clinical development for amyotrophiclateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):5-10. 20. Wong C, Stavrou M, Elliott E, et al. Clinical trials in amyotrophic lateral sclerosis: a systematic review and perspective. Brain Commun. 2021;3(4): fcab242. 21. Cedarbaum JM, Stambler N, Malta E, et al; BDNF ALS Study Group (Phase III). The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. J Neurol Sci. 1999;169(1-2):13-21. 22. Castrillo-Viguera C, Grasso DL, Simpson E, et al. Clinical significance in the change of decline in ALSFRS-R. Amyotroph Lateral Scler. 2010;11(1-2):178-180. 23. Genge A, Pattee GL, Sobue G, et al. Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment. Muscle Nerve. 2023;67(2):124-129. 24. Singh P. P value, statistical significance and clinical significance. J Clin Prev Cardiol. 2013;2(4):202-204. 25. Grad LI, Rouleau GA, Ravits J, et al. Clinical spectrum of amyotrophic lateral sclerosis (ALS). Cold Spring Harb Perspect Med. 2017;7(8):a024117. 26. Leigh PN, Swash M, Iwasaki Y, et al. Amyotrophic lateral sclerosis: a consensus viewpoint on designing and implementing a clinical trial. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004;5(2):84-98.
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.
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.
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.
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.
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information.
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.
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.
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.
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.
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information.
RADICAVA, RADICAVA ORS, the RADICAVA logo, the RADICAVA ORS logo, and the corporate symbol of Mitsubishi Tanabe Pharma America are registered trademarks of Mitsubishi Tanabe Pharma Corporation.
JourneyMate Support Program is a trademark of Mitsubishi Tanabe Pharma America, Inc.
All other company names, product names, trade/service marks or other trade names are the property of their respective owners.
For US Healthcare Professionals Only.
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