Shionogi Strengthens Rare Disease Portfolio with Full Acquisition of RADICAVA (Edaravone)
Shionogi & Co., Ltd. has officially completed the acquisition of all rights to RADICAVA (edaravone), marking a major milestone in the company’s strategic expansion into rare diseases. The transition was executed with full operational readiness on day one, ensuring uninterrupted access to treatment for patients living with amyotrophic lateral sclerosis (ALS).
As part of this transition, more than 100 team members from Tanabe Pharma America have joined Shionogi, bringing with them extensive expertise and continuity in patient care, commercial operations, and clinical support. This seamless integration underscores Shionogi’s commitment to maintaining strong relationships with the ALS community while advancing its broader rare disease strategy.
The acquisition includes intellectual property and commercial rights for RADICAVA across major global markets, with additional regional transfers expected in the near future. By incorporating established programs, talent, and infrastructure, Shionogi is positioning itself as a competitive and commercially capable leader in the rare disease space.
Building a Strong Rare Disease Commercial Platform
The acquisition of RADICAVA is a cornerstone in Shionogi’s long-term vision to become a global leader in rare diseases. Beyond securing a marketed therapy, the company has gained a fully operational commercial platform that will support future product launches and pipeline expansion.
Shionogi’s leadership emphasized that this move is not solely about acquiring a product but about building a sustainable ecosystem for innovation and patient support. The integration of experienced personnel and established operational systems enables the company to accelerate its rare disease ambitions, particularly in markets such as the United States.
The company expects the transaction to be immediately accretive, contributing approximately $700 million in annual global sales beginning in fiscal year 2026. This financial boost will further strengthen Shionogi’s ability to invest in research, development, and commercialization of therapies targeting unmet medical needs.
Commitment to ALS Community and Unmet Medical Needs
RADICAVA is approved by the U.S. Food and Drug Administration (FDA) and regulatory authorities worldwide for the treatment of ALS, a progressive and fatal neurodegenerative disorder. The disease is characterized by the gradual loss of motor neurons, leading to muscle weakness, loss of mobility, and ultimately respiratory failure.
To date, more than 22,000 patients in the United States have been treated with RADICAVA, including both its intravenous formulation and the oral suspension version, RADICAVA ORS. These therapies aim to slow functional decline in ALS patients, offering one of the limited treatment options available.
Shionogi’s CEO, Isao Teshirogi, Ph.D., highlighted the significance of the acquisition in advancing the company’s mission. He stated that the move aligns with Shionogi’s 2030 Vision, which focuses on delivering innovative medicines and improving patient outcomes globally. He also emphasized the company’s responsibility to support the ALS community and ensure continued access to effective therapies.
Expanding Innovation and Future Development
With the addition of RADICAVA, Shionogi is not only strengthening its current portfolio but also laying the groundwork for future innovation. The company is actively developing therapies across multiple rare disease indications, including Fragile X syndrome, Jordan’s Syndrome, and Pompe disease.
The integration of RADICAVA’s commercial and clinical infrastructure provides a strong foundation for launching future treatments. Shionogi aims to leverage this platform to accelerate development timelines and enhance patient access to new therapies.
Nathan McCutcheon, President and CEO of Shionogi Inc., expressed confidence in the company’s ability to expand its rare disease franchise. He noted that the addition of experienced team members from Tanabe will play a critical role in achieving operational excellence and delivering innovative solutions to patients.
Clinical Profile and Safety Information
RADICAVA ORS (edaravone) is specifically indicated for the treatment of ALS. While it has demonstrated clinical benefits, it is important to consider its safety profile.
Hypersensitivity Reactions
RADICAVA ORS is contraindicated in patients with known hypersensitivity to edaravone or its components. Reported reactions include redness, hives, and more severe conditions such as anaphylaxis. Patients receiving treatment should be closely monitored, and therapy should be discontinued if adverse reactions occur.
Sulfite Sensitivity
The formulation contains sodium bisulfite, which may trigger allergic reactions, particularly in individuals with asthma. These reactions can range from mild symptoms to severe, life-threatening episodes.
Common Adverse Reactions
Clinical studies have identified several common side effects associated with RADICAVA treatment. These include contusion, gait disturbances, and headaches. Additionally, fatigue has been observed in some patients receiving the oral formulation.
Pregnancy Considerations
Based on animal studies, RADICAVA ORS may pose risks to fetal development. Healthcare providers are advised to carefully evaluate the benefits and risks when prescribing the medication to pregnant patients.
Understanding ALS: A High Unmet Medical Need
Amyotrophic lateral sclerosis is a rare but devastating condition with no known cure. The disease progresses rapidly, often leading to significant disability and reduced life expectancy.
Globally, ALS affects approximately 1 to 2 individuals per 100,000 population annually. Despite ongoing research, treatment options remain limited, primarily focusing on slowing disease progression rather than reversing damage.
The underlying mechanisms of ALS are complex and involve factors such as oxidative stress and glutamate-induced toxicity. These challenges highlight the urgent need for continued innovation and investment in therapeutic development.
By acquiring RADICAVA and expanding its research efforts, Shionogi is contributing to the global effort to address this critical unmet medical need.
Strategic Vision and Corporate Commitment
Founded over 140 years ago, Shionogi & Co., Ltd. has established itself as a research-driven pharmaceutical company dedicated to improving patient health and well-being. The company’s portfolio spans multiple therapeutic areas, including infectious diseases, central nervous system disorders, pain management, and cardiovascular conditions.
In recent years, Shionogi has sharpened its focus on areas with high unmet need, particularly rare diseases and CNS-related conditions. The acquisition of RADICAVA aligns with this strategic direction, reinforcing the company’s commitment to delivering innovative and impactful therapies.
Looking ahead, Shionogi plans to continue investing in research and development while expanding its global presence. The company’s rare disease platform will serve as a key driver of growth, enabling it to bring new treatments to patients who currently have limited options.
The completion of RADICAVA’s acquisition represents a transformative step for Shionogi. By combining a proven therapy with an experienced team and established infrastructure, the company is well-positioned to lead in the rare disease space.
Most importantly, the seamless transition ensures that ALS patients will continue to receive uninterrupted care and support. As Shionogi advances its pipeline and explores new therapeutic opportunities, its commitment to innovation and patient-centric care remains at the forefront.
This strategic move not only strengthens Shionogi’s commercial capabilities but also reinforces its role as a trusted partner in addressing some of the most challenging diseases affecting patients worldwide.
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.1
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 22,000 people with ALS, with over 2.8-million days of therapy, and have been prescribed by over 2,800 HCPs.2,3
