Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that the U.S. Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity (ODE) for RADICAVA ORS ® (edaravone) based on their assessment that the oral form of edaravone constitutes a major contribution to patient care for people living with amyotrophic lateral sclerosis (ALS).
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Orphan Drug Exclusivity recognized for RADICAVA ORS based on major contribution to patient care JERSEY CITY, N.J., April 8, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma Corporation (MTPA) today announced that the U.S. Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity (ODE) for RADICAVA ORS® (edaravone) based on their assessment that the oral form of edaravone constitutes a major contribution to patient care for people living with amyotrophic lateral sclerosis (ALS). The FDA's Orphan Drug program is designed to support the development of drugs that treat rare diseases which affect less than 200,000 people in the U.S. Previously, the FDA granted RADICAVA ORS Priority Review and Fast Track designations.
The FDA recognized ODE for RADICAVA ORS because it provides a clinically superior option for patients due to its oral suspension route of administration that can help reduce the burden patients face with intravenous (IV) administration of previously approved RADICAVA® (edaravone). RADICAVA ORS is self-administered, can be taken orally or via feeding tube, comes in a portable bottle with an oral dosing syringe and no need for patients to refrigerate or reconstitute before taking. With appropriate instruction from a healthcare provider (HCP), RADICAVA ORS may take only a few minutes to administer on treatment days and should be taken in the morning after overnight fasting.1 "I'm thrilled at the FDA's recognition of ODE to RADICAVA ORS," said Stanley H. Appel, MD, Houston Methodist Stanley H. Appel Department of Neurology. "This comes at a critical time in the ALS treatment landscape and helps ensure that our patients and HCPs have a treatment option validated for several years, including by the pivotal Phase 3 clinical trial." The U.S. approval of RADICAVA® (edaravone) was based on the pivotal Phase 3 study (Study 19 or MCI186-19), in which RADICAVA was shown to slow the loss of physical function by 33 percent in 68 patients vs. placebo (n=66 patients), measured over a 24-week time period by the ALS Functional Rating Scale-Revised (ALSFRS-R).1 On average, patients on RADICAVA lost 2.49 fewer points on the ALSFRS-R vs. those in the placebo arm (p=0.0013).1,2 RADICAVA ORS offers the same efficacy as RADICAVA in a different formulation.1,2 The safety profile of RADICAVA was demonstrated in pooled placebo-controlled trials in which 184 patients with ALS were administered RADICAVA (60 mg) in 24-week treatment cycles.1 The safety profile of RADICAVA ORS was demonstrated in a 6-month, Phase 3, open-label clinical trial in 185 patients. Please see Important Safety Information below and Full Prescribing Information here. "We recognize the profound impact that an oral formulation has on the ALS community, in part by offering a less burdensome option for people living with ALS," said Calaneet Balas, President & CEO, ALS Association. "We thank Mitsubishi Tanabe Pharma America for continuing their efforts to help provide treatments to people living with ALS." To date, in the U.S., over 14,600 people living with ALS have been treated with RADICAVA and RADICAVA ORS and has been prescribed by over 2,300 HCPs.3,4 Both formulations are supported by a robust set of data from multiple clinical trials, post-hoc analysis and real-world evidence (RWE) studies evaluating the efficacy and safety. These results have been published in over 40 peer-reviewed articles. About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone) 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 14,600 people with ALS, with over 1.8-million days of therapy, and have been prescribed by over 2,300 HCPs.3-5 IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions 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 Adverse Reactions Pregnancy 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 For more information, including full Prescribing Information, please visit www.RADICAVA.com. About Mitsubishi Tanabe Pharma America, Inc. About Mitsubishi Tanabe Pharma Corporation Media inquiries: 1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
SOURCE Mitsubishi Tanabe Pharma America |
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Company Codes: NASDAQ-NMS:SYNH |
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