Efficacy & Safety

Study Protocol

The efficacy of Radicava® (edaravone) was demonstrated in a Phase 3, double-blind, parallel-group, clinical trial.1,2

radicava efficacy chart
  • Limited to 6 months for ethical considerations2,*
  • Patients who completed the observation period were randomized to Radicava® or placebo1

*By Japan's Ministry of Health, Labor, and Welfare and investigators.

Riluzole was received concomitantly by >90% of study participants.1

Study Design

Effect on Physical Function

In a pivotal clinical trial, Radicava® was shown to slow the decline of physical function in people with amyotrophic lateral sclerosis (ALS), as measured by total score on the ALS Functional Rating Scale–Revised (ALSFRS-R).1

Physical Function in Daily Activities at 6 Months1,2

Mean Change in ALSFRS-R Score (LOCF)
LS Mean ± SE
radicava efficacy chart
Change in ALSFRS-R Score from Baseline
LS Mean ± SE
radicava efficacy chart
radicava efficacy chart

Distribution of Change in ALSFRS-R Scores1

From Baseline to Week 24
radicava efficacy chart

Safety of Radicava

Common adverse reactions

The safety of Radicava® was demonstrated in pooled placebo-controlled trials* in which 184 patients with ALS were administered Radicava® (60 mg) in treatment cycles for 6 months.1

Below are adverse reactions that occurred in ≥2% of patients treated with Radicava® and ≥2% more frequently than in placebo-treated patients.1

Adverse Reactions Radicava
(n=184)
Placebo
(n=184)
Contusion 15% 9%
Gait disturbance 13% 9%
Headache 10% 6%
Dermatitis 8% 5%
Eczema 7% 4%
Respiratory failure, respiratory disorder, hypoxia 6% 4%
Glycosuria 4% 2%
Tinea infection 4% 2%

*Pooled placebo-controlled studies include two additional studies with 231 additional patients, all using the same treatment regimen.1

Serious adverse reactions

Radicava® may cause serious adverse reactions (ARs), including1:

  • Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea). If hypersensitivity reactions occur, discontinue Radicava®, treat per standard of care, and monitor until the condition resolves
  • Sulfite allergic reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people

Patients should be monitored carefully for all serious ARs. For more details, see the full Prescribing Information.

radicava efficacy

Discontinuations

In the Phase 3 clinical trial, more patients who received Radicava® remained in the study for the full 6 months compared to those who received placebo.2

radicava efficacy chart

Specific Populations

Pharmacokinetics

In clinical trials, no differences in pharmacokinetics were found in1:

radicava efficacy 1
Geriatric patients
29% were age 65 and older
radicava efficacy 2
Gender
59% were male
radicava efficacy 3
Japanese and Caucasian Patients

No pharmacokinetic data are available in patients with renal impairment or hepatic impairment.1

radicava efficacy chart

Nearly 30% of patients were >65 years

Use in Geriatric Patients

Of the 184 patients who received Radicava® in 3 placebo-controlled trials, 53 were 65 years of age and older, including 2 who were 75 years of age and older.1

  • No overall differences in safety or effectiveness were observed between these patients and younger patients
  • Greater sensitivity of some older individuals cannot be ruled out

Use in other specific populations1

  • Pregnancy: there are no adequate data on the developmental risk associated with the use of Radicava® in pregnant women
  • Lactation: there are no data on the presence of edaravone in human milk, the effects on the breastfed infant, or the effects of the drug on milk production
  • Pediatric: safety and effectiveness of Radicava® in pediatric patients have not been established
  • Renal impairment: the effect of renal impairment on the pharmacokinetics of Radicava® has not been studied
  • Hepatic impairment: the effect of hepatic impairment on the pharmacokinetics of Radicava® has not been studied

To learn more, please see the full Prescribing Information.


Hear an Expert Discussion

More information about efficacy, safety, and
clinical outcomes for Radicava® is available.

References: 1. Radicava Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America; 2017. 2. Data on file. Mitsubishi Tanabe Pharma America.

Important Safety Information

Hypersensitivity Reactions

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.

Pregnancy

Based on animal data, Radicava® may cause fetal harm.

Geriatric Use

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.

Indication

Radicava® is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Please see full Prescribing Information.