Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for an investigational oral formulation of edaravone (MT-1186) for the treatment of amyotrophic lateral sclerosis (ALS).
| JERSEY CITY, N.J., Jan. 12, 2022 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for an investigational oral formulation of edaravone (MT-1186) for the treatment of amyotrophic lateral sclerosis (ALS). The FDA has accepted the application for priority review with a Prescription Drug User Fee Act (PDUFA) action date of May 12, 2022. The FDA grants Priority Review for medicines that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.1
Investigational oral edaravone has been developed to have a similar clinical profile compared to the intravenous (IV) formulation of RADICAVA® (edaravone), which was approved by the FDA for the treatment of ALS in May 2017.2 “At MTPA, we thrive on tackling the toughest challenges and are focused on addressing the unmet needs of the ALS community, which is illustrated by our ongoing development program for edaravone,” said Atsushi Fujimoto, President, MTPA. “Our top priority is to help ensure ALS patients have flexibility with treatment and formulation options that are right for their specific needs. We look forward to working with the FDA in the coming months to bring this new formulation to patients as soon as possible.” The comprehensive clinical development program for edaravone in ALS has spanned over a decade and included multiple clinical trials for the IV and the investigational oral formulation. The NDA is supported by data from the RADICAVA IV pivotal trial and upwards of seven Phase 1 clinical pharmacology studies examining the pharmacokinetics, safety, drug-drug interactions, dosing, bioavailability and bioequivalence of the oral suspension in healthy individuals and ALS patients with and without PEG/NGT, along with a Phase 3 clinical trial evaluating the safety and tolerability of the investigational oral suspension over the course of 24 weeks in patients with ALS. There is an ongoing study evaluating the safety and tolerability of the oral suspension at 48 and 96 weeks. “Oral edaravone may provide another formulation option for ALS patients looking for an alternate mode of administration,” said Terry Heiman-Patterson, M.D., Professor, Neurology, Lewis Katz School of Medicine at Temple University, Director, Temple MDA/ALS Center of Hope. “We know that every patient living with ALS has their own unique needs, and I’m hopeful that an oral suspension formulation will offer a new and much needed option.” About Oral Edaravone (MT-1186) In 2019, Mitsubishi Tanabe Pharma group companies completed a series of Phase 1 studies comparing the oral formulation and intravenous formulations of edaravone and have started a global, multi-center, open-label, Phase 3 clinical trial evaluating safety and tolerability of oral edaravone in 185 patients with ALS across approximately 50 sites in the U.S., Canada, Europe and Japan. More information on the clinical trials is available at ClinicalTrials.gov (NCT04165824 and NCT04577404). About RADICAVA® (edaravone) IV INDICATION IMPORTANT SAFETY INFORMATION
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of RADICAVA?
The most common side effects of RADICAVA include bruising (contusion), problems walking (gait disturbance), and headache. These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For more information, including full Prescribing Information and Patient Information, please visit www.RADICAVA.com. About Mitsubishi Tanabe Pharma America, Inc. About Mitsubishi Tanabe Pharma Development America, Inc. About Mitsubishi Tanabe Pharma Corporation Media inquiries: 1 U.S. Food and Drug Administration. Priority Review. FDA website. Accessed November 2021. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review.
SOURCE Mitsubishi Tanabe Pharma America, Inc. |
View original content to download multimedia:
