Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter, “Shionogi”) today announced the four-year anniversary of RADICAVA ORS® (edaravone), the only oral formulation of edaravone approved by the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis (ALS).

To date, RADICAVA ORS has been prescribed by approximately 1,640 physicians in the U.S., with about 810 physicians prescribing it monthly to more than 4,500 people for the treatment of ALS.1

“As we continue to support the ALS community, we are proud to continue the strong legacy of RADICAVA ORS and its role as an important treatment option for people living with ALS,” said Nathan McCutcheon, MBA, President and CEO, Shionogi Inc. “At the same time, we recognize that this is only one step in a much broader journey, and we remain focused on the work still to be done to further innovation and meet the urgent needs of the ALS community.”

Approved by the FDA in May 2022, RADICAVA ORS is an oral formulation that offers the same efficacy as the previously available intravenous (IV) RADICAVA® (edaravone).2,3 In a pivotal Phase 3 clinical trial of RADICAVA (n=68), treatment with edaravone slowed the loss of physical function by 33% compared with placebo (n=66) at 24 weeks, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R).3,4 Common side effects reported include bruising (contusion), problems walking (gait disturbance), headache and fatigue. These are not all the possible side effects of RADICAVA ORS.

“In my practice, I see firsthand how urgently patients and families need treatment options that are both meaningful and practical in the context of daily life,” said Jinsy A. Andrews, M.D., director of the NYU Langone ALS Center. “Having an oral option has been helpful in shaping treatment plans and enabling more personalized, patient-centered decision-making.”

Shionogi remains committed to advancing the ALS community’s understanding of edaravone through continued education and the generation of critical data, including real-world evidence, biomarker research, and additional analyses from prior clinical trials.

Beyond treatment, Shionogi recognizes the importance of helping patients and families feel supported throughout their ALS journey and offers the JourneyMate Support Program™ to provide resources and education about RADICAVA ORS. For more information on JourneyMate, visit: https://www.radicava.com/patient/journeymate/ or call 1-855-457-6968 between 9 a.m. and 9 p.m. ET, Monday through Friday.

About RADICAVA ORS® (edaravone)

The U.S. Food and Drug Administration (FDA) approved RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA granted RADICAVA ORS Orphan Drug Exclusivity based on its major contribution to patient care by providing an oral suspension route of administration that avoids the burdens of IV administration. 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. Each 105 mg (5mL) dose of 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.3

Edaravone was discovered and developed for ALS by Tanabe Pharma and commercialized in the U.S. by Tanabe Pharma America, Inc. The Tanabe Pharma group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021), Australia (February 2023) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA ORS, along with the previously available IV RADICAVA® (edaravone), have been used to treat over 22,800 people with ALS, with over 3.0-million days of therapy, and have been prescribed by over 2,850 HCPs.1

INDICATION

RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions

RADICAVA ORS® (edaravone) is 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.

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

Sulfite Allergic Reactions

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® (edaravone)-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.

Pregnancy

Based on animal data, RADICAVA ORS may cause fetal harm.

To report SUSPECTED ADVERSE REACTIONS, contact Shionogi Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information, also available at www.RADICAVAORS.com.

About ALS

ALS (Amyotrophic Lateral Sclerosis) is a progressive neurodegenerative disease characterized by the selective degeneration and loss of motor neurons, leading to muscle weakness and respiratory impairment. After onset, muscle atrophy gradually progresses, and ultimately respiratory muscle paralysis severely impacts life expectancy. Globally, the annual incidence is estimated at approximately 1–2 cases per 100,000 population, making it a rare disease for which no fundamental cure currently exists.5 Multiple factors, including oxidative stress and glutamate-induced excitotoxicity, are involved in its pathophysiology, and treatment options to slow disease progression remain extremely limited. For this reason, ALS is recognized as a disease with a high level of unmet medical need, and the development and delivery of innovative therapies are strongly required.

About Shionogi & Co., Ltd.

Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, and CNS disorders. and cardiovascular diseases. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer’s disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en.

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

References

  1. Data on file. Shionogi Inc.

  2. 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.

  3. RADICAVA and RADICAVA ORS [package insert]. Florham Park, NJ: Shionogi Inc.

  4. Shimizu H, 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. Xu, et al. Global variation in prevalence and incidence of amyotrophic lateral sclerosis: a systematic review and meta-analysis. J Neurol. 2020 Apr;267(4):944-953. DOI: 10.1007/s00415-019-09652-y

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