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To better understand <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS) and improve patient care, <a href="https://www.mt-pharma-america.com/" rel="nofollow">Mitsubishi Tanabe Pharma America</a> (MTPA) is partnering with the <a href="https://www.data4cures.org/natural-history-consortium">ALS/MND Natural History Consortium</a> in collecting real-world data on people with the progressive neurodegenerative disorder.
The collaboration will give MTPA access to the consortium&#8217;s data repository, containing demographic, baseline, and longitudinal clinical and scientific data on people with ALS and other motor neuron disorders (MNDs).
The company also will gain access to clinical data covering patients using its ALS treatments, <a href="https://alsnewstoday.com/radicava-edaravone-for-als/">Radicava</a> (edaravone) and the oral formulation <a href="https://www.radicava.com/patient/taking-radicava-ors/">Radicava ORS</a>, dating back when the consortium was founded in 2015.
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<h3>Radicava&#8217;s 2017 approval marked first new ALS treatment for US in 22 years</h3>
Both formulations were developed by <a href="https://www.mt-pharma.co.jp/e/" rel="nofollow">Mitsubishi Tanabe Pharma</a> and are marketed in the U.S. by its subsidiary MTPA. They are used to slow functional decline and extend survival in those with ALS.
When Radicava was <a href="https://alsnewstoday.com/news/fda-approves-radicava-first-new-als-therapy-in-20-years-and-cause-for-hope/">approved by the U.S. Food and Drug Administration in 2017</a>, preceded by approvals in Japan and South Korea, it became the first new ALS treatment available in the U.S. in more than 20 years. To date, the formulations have been used to treat some 10,000 ALS patients in that country, according to MTPA.
&#8220;Access to real-world data is critical with complex and difficult-to-treat diseases like ALS,&#8221; Gustavo A. Suarez Zambrano, MD, MTPA vice president of medical affairs, said in a <a href="https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-to-partner-with-alsmnd-natural-history-study-consortium-to-collect-real-world-data-in-als-with-the-goal-of-improving-patient-care-301843078.html">company press release</a>. &#8220;This collaboration will enable us to leverage a comprehensive database of real-world and retrospective clinical trial findings, continuously advancing our scientific understanding of ALS and how to improve care for people living with this disease.&#8221;
More than 2,100 ALS patients from across 10 participating clinics in the U.S. and Italy are currently enrolled in the consortium. Its database uses NeuroBANK, a patient-centric clinical research platform managed by the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital (MGH).
The consortium&#8217;s mission is to collect real-world ALS and MND data that could aid scientists in disease research and help to inform clinical trial design. The overarching aim is improved ALS knowledge and care.
&#8220;Through this collaboration, MTPA joins the ranks of visionary companies that understand the importance of capturing high-quality real-world data that help us to better understand, better diagnose and ultimately find new treatment options for ALS,&#8221; said Alex Sherman, director of the Center for Innovation and Biomedical Informatics at the NCRI and the study&#8217;s principal investigator. &#8220;We hope to see this momentum continue and are confident our collaboration with MTPA will have a meaningful impact on the ALS community.&#8221;

MTPA joins with ALS/MND patient registry with goal of better care

Radicava ORS, an oral formulation of <a href="https://alsnewstoday.com/radicava-edaravone-for-als/">Radicava</a> (edaravone), is now available to U.S. veterans living with <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS), the therapy’s developer, <a href="https://www.mt-pharma-america.com/" rel="nofollow">Mitsubishi Tanabe Pharma America</a> (MTPA), announced.
The therapy was added to the U.S. Department of Veterans Affairs National Formulary (VANF) in June 2022, shortly after its May <a href="https://alsnewstoday.com/news/fda-approves-radicava-ors-oral-suspension-edaravone-als/">approval by the U.S. Food and Drug Administration</a> (FDA). This was an initial step in making Radicava ORS available to service members who are part of the Veterans Affairs&#8217; (VA) integrated healthcare system.
Approval at the national level also is required for <a href="https://www.va.gov/formularyadvisor/drugs/4041481-EDARAVONE-SUSP-ORAL">dispensing this medication</a>, and that process now is &#8220;in place,&#8221; MTPA reported, making the treatment available to patients within the VA system.
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<h3>Radicava in an oral suspension formulation can be taken at the home</h3>
&#8220;Given the devastating nature of ALS and the demand for additional treatment options, we are thrilled to see Radicava ORS added to the VA&#8217;s National Formulary,&#8221; Atsushi Fujimoto, MTPA’s president, said in a <a href="https://www.prnewswire.com/news-releases/radicava-ors-edaravone-added-to-us-department-of-veterans-affairs-national-formulary-301768724.html">company press release</a>.
The VANF comprises a <a href="https://www.pbm.va.gov/PBM/nationalformulary/VA_National_Formulary_FEB_2023.xlsx">list of prescription medications</a> and products available across all VA facilities. Its goal is to ensure a therapy is appropriate and safe for patient use, with criteria that follows the FDA&#8217;s approval label for a treatment.
&#8220;Some studies have shown that military veterans are twice as likely to develop ALS than those who haven&#8217;t served in the military,&#8221; said Juan Reyes, a U.S. veteran with ALS and patient ambassador for MTPA.
&#8220;The addition of Radicava ORS to the VA National Formulary symbolizes not only the dedication and recognition of veterans by MTPA and the VA, but also a significant step forward for those in the ALS community in need of an alternate treatment option,&#8221; Reyes added.
Radicava ORS is an oral formulation of edaravone, a medication that works to slow ALS progression by reducing oxidative damage to cells. Oxidative stress is believed to drive nerve cell death, as neurons are particularly sensitive to it.
FDA approval was based on data showing that Radicava ORS delivers similar amounts of edaravone to the body as the intravenous (into-the-vein) infusion formulation of Radicava, and seems to be equally effective at slowing disease progression.
As a therapy that can be self-administered at home, taken by mouth or via feeding tube, it can be more convenient and easier to use less than Radicava.
The oral therapy follows the same dosing regimen as the infusion treatment, with both administered in 28-day cycles. In a first treatment cycle, Radicava ORS is taken daily for 14 days, followed by 14 days without treatment. Subsequent treatment cycles consist of daily dosing for 10 of 14 consecutive days, followed by 14 days (two weeks) of no treatment.
Patients are advised to take Radicava ORS in the morning, after overnight fasting, and to not eat — drinking only water, if wanted — for one hour after the drug&#8217;s administration.
The oral formulation of edaravone is also <a href="https://alsnewstoday.com/news/radicava-oral-suspension-approved-canada-treat-als/">approved in Canada</a>, where it is sold as Radicava Oral Suspension, and Japan, where it is marketed as Radicut Oral Suspension 2.1%.

Radicava ORS, oral form of edaravone, available to US veterans

An oral suspension form of <a href="https://alsnewstoday.com/radicava-edaravone-for-als/">Radicava</a> (edaravone), an approved treatment of <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS), was favored for patient reimbursement in Canada by a branch of the Canadian Agency for Drugs and Technologies in Health (CADTH).
The opinion issued by the CADTH Canadian Drug Expert Committee recommended that Radicava Oral Suspension be reimbursed through the public drug plans of the country&#8217;s provinces and territories.
Certain conditions must be met, including a prescription for this formulation and the cost of oral Radicava not exceeding that of Radicava in its initial intravenous formulation.
&#8220;The positive recommendation from CADTH is an important first step in ensuring access to Radicava Oral Suspension for all eligible Canadians living with ALS,&#8221; Atsushi Fujimoto, president of <a href="https://www.mt-pharma-ca.com/" rel="nofollow">Mitsubishi Tanabe Pharma Canada</a>, said in a <a href="https://www.newswire.ca/news-releases/radicava-r-edaravone-oral-suspension-receives-positive-recommendation-from-cadth-for-the-treatment-of-patients-with-als-882129765.html">company press release</a>.
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<h3>Oral Radicava can be taken at the home by mouth or feeding tube</h3>
CADTH&#8217;s recommendation is nonbinding, with the public drug plans of each province and territory deciding whether to list the oral medication based on the agency&#8217;s recommendation and factors such as its own priorities and resources.
Mitsubishi Tanabe Pharma Canada, a subsidiary of <a href="https://www.mt-pharma-america.com/" rel="nofollow">Mitsubishi Tanabe Pharma America</a> that markets Radicava in Canada,  stated it will continue to work with insurance companies and public agencies to make Radicava Oral Suspension available to patients via public formularies and private insurance. Public formularies are lists of prescription treatments covered as benefits for those eligible.
&#8220;While we are delighted by this milestone, we know there is more work to do, and we look forward to continued discussions with stakeholders to secure coverage for Radicava Oral Suspension on public formularies,&#8221; Fujimoto said.
Oxidative stress is seen as a central mechanism in the neuronal damage taking place in ALS. Radicava is a free-radical scavenger, meaning it helps to remove the reactive molecules that can contribute to oxidative stress to lessen nerve damage and slow ALS progression.
The intravenous (IV) formulation was <a href="https://alsnewstoday.com/news/radicava-now-approved-to-treat-als-patients-in-canada/">approved in Canada</a> in 2018, and patients using it are <a href="https://als.ca/blogs/access-to-therapies-radicava-edaravone-update/">reimbursed through public formularies</a> across Canada, as well as via the Veterans Affairs Canada and Indigenous Services Canada.
Radicava Oral Suspension, <a href="https://alsnewstoday.com/news/radicava-oral-suspension-approved-canada-treat-als/#:~:text=Radicava%20Oral%20Suspension%2C%20an%20oral%20formulation%20of%20edaravone%2C,in%20Canada%20for%20treating%20amyotrophic%20lateral%20sclerosis%20%28ALS%29.">approved by Health Canada</a> in November, was developed to be as effective as Radicava IV but more convenient.  It n can be self-administered at home, either by mouth or via a feeding tube, while Radicava IV is infusion treatment administered at a center, with each infusion lasting about one hour.
Available as <a href="https://www.radicava.com/patient/taking-radicava-ors/">Radicava ORS</a> in the U.S., the medication comes in a portable bottle and includes a 5 mL oral syringe for accurate dosing. It should be taken at a dose of 105 mg (the equivalent to 5 mL of the solution) in the morning after overnight fasting. Patients are recommended to take only water for one hour after administration.
The oral formulation is given in the same dosing regimen as Radicava IV: in a first cycle, patients receive daily dosing for 14 days, followed by a two-week treatment-free period. In subsequent cycles, the medication is given for 10 of the first 14 days, followed by two weeks with no treatment.
U.S. and Canadian approvals of Radicava Oral Suspension were supported by clinical trials showing that the oral formulation delivers similar amounts of edaravone, its active ingredient, to the body.
They also were based on interim results of the open-label <a href="https://clinicaltrials.gov/ct2/show/NCT04165824">Phase 3 trial (NCT04165824)</a> in 185 ALS patients, which showed that six months of treatment with Radicava Oral Suspension was <a href="https://alsnewstoday.com/news/oral-edaravone-appears-safe-patients-interim-trial-data/">generally well tolerated and slowed functional decline</a>.

Tag: Radicava

MTPA joins with ALS/MND patient registry with goal of better care

Radicava ORS, oral form of edaravone, available to US veterans

Radicava Oral Suspension Favored for Reimbursement in Canada