JERSEY CITY, N.J., Oct. 15, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced three presentations at the 2024 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) Annual Meeting being held in Savannah, GA, October 15-18. The presentations will feature amyotrophic lateral sclerosis (ALS) research, including findings from the Phase 3b study (MT-1186-A02), which evaluated the superiority of daily dosing of RADICAVA ORS® (edaravone) compared to the FDA-approved on/off regimen, as well as preclinical data on the effect of edaravone on spinal motor neurons derived from an ALS patient harboring a TDP-43 mutation.
“In our ongoing commitment to advancing ALS care, we are proud to share our latest research at the 2024 AANEM Annual Meeting,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “These findings reflect our unwavering dedication to deepening our understanding of ALS and exploring treatment approaches that could make a meaningful difference for people living with ALS.”
RADICAVA ORS
Presentations include final results from the global, multi-center, double-blind, Phase 3b MT-1186-A02 study, which assessed the superiority of daily dosing of RADICAVA ORS compared to the standard FDA-approved on/off regimen. The study confirmed that daily dosing of oral edaravone showed no significant difference and did not demonstrate superiority, further supporting the suitability of the FDA-approved regimen. Additionally, findings from the open-label, multi-center Phase 3 extension study MT-1186-A03 will be shared, evaluating the long-term safety of RADICAVA ORS over a 96 week-period in patients who previously completed the initial 48-week study (MT-1186-A01).
- Phase 3b Study MT-1186-A02 to Investigate the Superiority of Daily Dosing vs the FDA-approved On/Off Regimen of Oral Edaravone in Patients with ALS
(Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA)
Poster Presentation: 6:15 p.m. – 6:45 p.m. ET, Wednesday, October 16 and 9:30 a.m. – 10:00 a.m. ET, Thursday, October 17
- Phase 3, Open-Label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03)
(Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA)
Poster Presentation: 6:15 p.m. – 6:45 p.m. ET, Wednesday, October 16 and 2:45 p.m. – 3:15 p.m. ET, Thursday, October 17
Preclinical Data
Results from a preclinical study that examined the effect of edaravone on spinal motor neurons derived from induced pluripotent stem cells (iPSC) from an ALS patient with the A382 TDP-43 mutation. The study provided evidence suggestive of the capacity of edaravone to induce transcriptomic changes leading to neuroprotection in ALS models, particularly those involving TDP-43 pathology.
- Transcriptomic Signature Induced by Edaravone in Motor Neurons From an ALS Patient With a TDP-43 Mutation
(Takayuki Shirakawa, Ph.D.; MTPA)
Poster Presentation: 6:15 p.m. – 6:45 p.m. ET, Wednesday, October 16 and 2:45 p.m. – 3:15 p.m. ET, Thursday, October 17
About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA recognized RADICAVA ORS with Orphan Drug Exclusivity based on the major contribution to patient care of the innovative oral formulation. RADICAVA is administered in 28-day cycles by intravenous (IV) infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period. 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. 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 Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC 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) 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 and RADICAVA ORS have been used to treat over 16,000 people with ALS, with over 2.0-million days of therapy, and have been prescribed by over 2,400 HCPs.2-4
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions
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.
Sulfite Allergic Reactions
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.Adverse Reactions
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.Pregnancy
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.
INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).For more information, including full Prescribing Information, please visit www.RADICAVA.com.
About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on X (formerly Twitter), Facebook and LinkedIn.About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, “Forging the future”. MTPC sets the MISSION of “Creating hope for all facing illness”. To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on “precision medicine” to provide drugs with high treatment satisfaction and additionally working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/.Media inquiries:
Media_MTPA@mt-pharma-us.com1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
2 Data on file. Mitsubishi Tanabe Pharma America, Inc.
3 Data on file. Mitsubishi Tanabe Pharma America, Inc.
4 Data on file. Mitsubishi Tanabe Pharma America, Inc.
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SOURCE Mitsubishi Tanabe Pharma America
