JERSEY CITY, N.J., October 6, 2021 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that five presentations on amyotrophic lateral sclerosis (ALS) will be shared as part of the 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting, being held virtually October 6–7.
“We look forward to sharing our latest research updates as we continue to work diligently to further understand the impact of treatment with RADICAVA® (edaravone) and the investigational oral formulation of edaravone, as well as EXSERVANTM (riluzole),” said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. “At MTPA, we thrive on tackling the toughest challenges, and we remain focused on seeking new information about treating ALS and continuing to advance research as part of our commitment to the ALS community.”
ALS data to be presented at NEALS include:
Oral Edaravone Development Program
Mitsubishi Tanabe Pharma Corporation (MTPC) will present an overview of the Phase 3 study design for an investigative oral formulation of edaravone, as well as the design of a clinical trial evaluating bioavailability of the oral formulation.
- Phase 3, Open-Label, Multicenter Safety Study of Oral Edaravone Administered Over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis: Study Design and Baseline Characteristics (MT-1186-A01) (Manabu Hirai, M.S., MTPC)
- Study Design for a Clinical Trial Assessing the Bioavailability of an Oral Formulation of Edaravone (M-1186) in Subjects with a Nasogastric Tube (Hidetoshi Shimizu, MTPC)
REFINE-ALS Biomarker Study
MTPA will present details on biomarker assays and COVID-19 mitigation strategies used in the REFINE-ALS Phase 4 study, for which MTPA aims to identify and measure specific biomarkers and clinical assessments in people with ALS.
- Biomarker Assays Utilized in the RADICAVA® (edaravone) Findings in Biomarkers from ALS (REFINE-ALS) Study (James Berry, M.D., M.P.H., Massachusetts General Hospital)
- COVID-19 Mitigation Strategies Utilized in the RADICAVA® (edaravone) Findings in Biomarkers from ALS (REFINE-ALS) Study (James Berry, M.D., M.P.H., Massachusetts General Hospital)
An analysis examining the outcomes of two clinical trials with EXSERVAN – one evaluating bioavailability and pharmacokinetics in a comparative bioavailability study of healthy adults and one videofluoroscopic swallowing study conducted with ALS patients – will be presented.
- Pharmacokinetics, Bioavailability, and Swallowing Safety with Riluzole Oral Film (James Wymer, D., Ph.D., C.P.I., F.A.A.N., University of Florida)
MT-1186 is an investigational oral formulation of edaravone being studied in patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed by researchers together with Mitsubishi Tanabe Pharma Corporation (MTPC), headquartered in Osaka, Japan. In May 2019, MTP group companies completed a series of Phase 1 studies administering the oral suspension and intravenous formulations of edaravone in healthy volunteers. More information on the oral edaravone development program 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 commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. 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 use as a treatment for ALS in Japan and South Korea. Marketing authorization was granted in Canada in October 2018 and Switzerland in January 2019.
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 EXSERVAN™ (riluzole) oral film
EXSERVAN, an oral film formulation of riluzole, was approved by the U.S. Food and Drug Administration (FDA) in November 2019. EXSERVAN was developed by Aquestive Therapeutics, Inc. using its PharmFilm® innovative drug delivery technology. The oral film is placed on top of the patient’s tongue and dissolves. Under the terms of a licensing and supply deal agreement, MTPA is commercializing EXSERVAN in the U.S. and Aquestive is serving as the exclusive sole manufacturer and supplier for the product. For more information, visit www.EXSERVAN.com.
EXSERVAN™ (riluzole) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to riluzole or to any of its ingredients.
Before using EXSERVAN, tell your doctor about all the medicines you take and all your health conditions, including if you:
- Have liver problems.
- Are taking certain drugs known as strong or moderate CYP1A2 inhibitors such as ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib, or zileuton.
- Are pregnant or intend to become pregnant during EXSERVAN therapy, or if you are breastfeeding or intend to breastfeed during EXSERVAN therapy.
EXSERVAN can cause serious side effects, including:
Liver Problems: Cases of liver injury, some fatal, have occurred in patients taking riluzole. Consult your doctor promptly if you experience unexplained nausea, vomiting, stomach (abdominal) pain, fatigue, weight loss (anorexia), jaundice (yellowing of the skin or whites of the eyes), and/or dark urine.
Low White Blood Cell Counts (Neutropenia): Tell your doctor if you develop a fever while taking EXSERVAN.
Serious Lung Problems (Interstitial Lung Disease): Tell your doctor if you have problems with your lungs or breathing such as dry cough and difficult or labored breathing. Discontinue EXSERVAN immediately if you develop interstitial lung disease.
The most common side effects include numbness in the mouth or tongue, muscle weakness, nausea, lung problems, high blood pressure, and stomach (abdominal) pain.
These are not all the possible side effects of EXSERVAN. Consult your doctor for medical advice about side effects.
To report side effects, contact Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use EXSERVAN as prescribed. The recommended dosage for EXSERVAN is 50 mg taken orally twice daily at least 1 hour before or 2 hours after a meal. Place EXSERVAN oral film strip on the top of the tongue where it will adhere and dissolve. Swallow in a normal manner. Do not cut or split the film or take liquids with EXSERVAN. Do not chew, spit, or talk while EXSERVAN is dissolving. Read the Instructions for Use for EXSERVAN.
Please click here to see the full Prescribing Information for EXSERVAN.
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 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.