Presentations Include New Real-World Data on IV Edaravone and Results from the Global Phase 3 Study of Investigational Oral Edaravone in the Treatment of ALS
JERSEY CITY, N.J., March 11, 2022 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that five presentations on amyotrophic lateral sclerosis (ALS) will be shared as part of the 2022 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, being held virtually and in Nashville, Tenn., March 13-16.
“We are dedicated to learning as much as possible about the clinical experience of edaravone in ALS, and look forward to sharing new data evaluating treatment outcomes in a real-world setting, and updates on the development program for investigational oral edaravone,” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “Putting patients first is our top priority, and as a part of our continued commitment to the ALS community, we are working tirelessly to increase our understanding of this devastating disease and its potential treatment options.”
MTPA’s posters will be viewable both in-person and virtually during the conference from March 13-15, and showcased in the Exhibit Halls from 6:00-8:00 p.m. CT. Key ALS data to be presented include:
An analysis of real-world treatment outcomes in patients with ALS treated with intravenous (IV) RADICAVA® (edaravone) will be presented, based on de-identified data collected from a provider of home and alternative-site infusions and specialty pharmacy services in the U.S. Patients with ALS who received their first dose of RADICAVA IV between Sept. 25, 2017, and Dec. 31, 2020, were included in the analysis.
- Real-world Treatment Outcomes Among Patients with Amyotrophic Lateral Sclerosis Receiving Intravenous Edaravone from a US Specialty Infusion Center (Melissa Hagan, PhD, M.D.; MTPA)
Oral Edaravone Development Program
24-week results from the global Phase 3 multi-center, open-label study (MT-1186-A01) of investigational oral edaravone in patients with ALS, as well as the study design from the ongoing, Phase 3 open-label extension study (MT-1186-A03) assessing the long-term safety and tolerability of oral edaravone in patients who completed A01, will be presented. Both A01 and A03 studies are conducted by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA). Additionally, the results of four Phase 1 open-label clinical pharmacology studies for oral edaravone in healthy subjects and patients with ALS will be presented.
- 24-Week Results From MT-1186-A01: A Phase 3, Open-Label, Multicenter Safety Study of Oral Edaravone in Patients with Amyotrophic Lateral Sclerosis (Angela Genge, M.D., FRCP; Montreal Neurological Institute and Hospital)
- Phase 3, Open-Label, Safety Extension Study of Investigational Oral Edaravone Administered Over 96 Weeks in Patients with ALS (MT-1186-A03) (Daniel Selness, R.N., B.A., MBA; MTDA)
- Pharmacokinetics and Bioequivalence Studies of an Investigational Oral Formulation of Edaravone (Stephen Apple, M.D.; MTPA)
- Phase 1 Study of Safety, Tolerability, and Bioavailability of Oral Edaravone Administered Orally and via a Nasogastric Feeding Tube (NGT) in Healthy Adults (Antoinette Harrison, PharmD, BCPP, BCGP, FASCP; MTPA)
To learn more about MTPA’s treatments and resources for patients living with ALS, explore the company’s virtual booth at MTPAProfessionalConnection.com.
About Oral Edaravone (MT-1186)
Oral edaravone is an investigational oral formulation of edaravone being developed by Mitsubishi Tanabe Pharma Corporation (MTPC) and Mitsubishi Tanabe Pharma Development America, Inc (MTDA). In the last three years, Mitsubishi Tanabe Pharma group companies completed 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 in patients with ALS with and without a PEG/NGT, and initiated two global, multicenter, open-label Phase 3 clinical trials evaluating the safety and tolerability of oral edaravone over the course of 24, 48 and 96 weeks in more than 120 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
The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) IV on May 5, 2017 as a treatment for amyotrophic lateral sclerosis (ALS).1 Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone IV was approved for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), China (July 2019), Indonesia (July 2020), and Thailand (April 2021).
RADICAVA is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
IMPORTANT SAFETY INFORMATION
Before you receive RADICAVA, tell your healthcare provider about all of your medical conditions, including if you:
- have asthma.
- are allergic to other medicines.
- are pregnant or plan to become pregnant. It is not known if RADICAVA will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if RADICAVA passes into your breast milk. You and your healthcare provider should decide if you will receive RADICAVA or breastfeed.
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?
- RADICAVA may cause serious side effects including hypersensitivity (allergic) reactions and sulfite allergic reactions.
- Hypersensitivity reactions have happened in people receiving RADICAVA and can happen after your infusion is finished.
- RADICAVA contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
- Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
- Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.
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.
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’s (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC to commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.
About Mitsubishi Tanabe Pharma Development America, Inc.
The U.S. headquarters of Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) is located in Jersey City, New Jersey. MTDA is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation’s 100 percent-owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. For more information, please visit https://mt-pharma-development-america.com/.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), founded in 1678, is one of the oldest pharmaceutical companies in the world. Focused on ethical pharmaceuticals, MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. In light of the anticipated changes in healthcare needs in the future, MTPC is advancing business activities under the mission of “Creating hope for all facing illness,” and has set the corporate vision for 2030 (VISION 30) to “Be a healthcare company that delivers optimal therapy to each individual.” As part of the vision for 2030, MTPC is prioritizing work on “precision medicine” to create effective therapies and preventive methods by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. In addition, MTPC is 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. MTPC is a member of Mitsubishi Chemical Holdings Group. For more information, go to https://www.mt-pharma.co.jp/e/.
- RADICAVA® (edaravone) U.S. Prescribing Information. March 2021.