JERSEY CITY, N.J., Aug. 9, 2021 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that nearly 6,000 people with amyotrophic lateral sclerosis (ALS) in the U.S. have received treatment with RADICAVA® (edaravone) since it became available to patients four years ago.
"The needs of patients are at the center of everything we do at MTPA," said Atsushi Fujimoto, President, MTPA. "Whether it's through ongoing analysis of real-world data or developing educational resources, our focus continues to be on making a difference for this community. We will never give up in the fight against this devastating disease."
Approximately 1,500 U.S. physicians have prescribed RADICAVA for their patients since 2017, when the therapy was approved by the U.S. Food and Drug Administration.
"An ALS diagnosis is a devastating experience for patients and their families," said Benjamin Rix Brooks, M.D., an ALS specialist and among the first physicians in the country to prescribe RADICAVA in the fall of 2017. "Four years ago, there had not been a new treatment for ALS approved in more than 20 years, and it was especially meaningful to be able to offer an option shown to delay functional loss, including in patients already on treatment with riluzole. After four years, we have been able to accrue further data describing real-world experience for patients with ALS treated with RADICAVA contributing to the overall body of knowledge in this area and ultimately will help inform patient treatment decisions for those suffering from ALS."
Over the last year, MTPA has worked to help advance the understanding of ALS and support the needs of those impacted by the disease in multiple ways, including:
Presented an analysis examining real-world data on the timing of disease progression milestones among commercially insured ALS patients treated with RADICAVA.
Conducted ongoing in-depth outcomes analysis utilizing a real-world de-identified database of administrative health claims across the U.S. to evaluate data among commercially insured ALS patients treated with RADICAVA, compared to a control group not prescribed the product. MTPA is conducting further analysis of real-world data with plans to submit the full results for publication in a peer-reviewed journal.
Continued implementation of comprehensive research into biomarkers in ALS, as well as updates to the REFINE-ALS biomarker study protocol to help address the logistical issues that arose during the COVID-19 pandemic. The amendment enabled patients to consent to participate virtually, with the option to utilize telemedicine and home health agencies in lieu of hospital or in-office visits.
Initiation of a clinical study utilizing an investigational oral form of edaravone (MT-1186). The study, sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), will meet a post-marketing commitment following the U.S. FDA approval of RADICAVA IV.
About RADICAVA® (edaravone) The U.S. Food and Drug Administration (FDA) approved RADICAVA® (edaravone) 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 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.
INDICATION 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:
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 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/.