U.S. Specialty Infusion Provider Data Analysis Shows Consistent
Results with Pivotal Phase 3 Study
JERSEY CITY, N.J., December 11, 2020 – Mitsubishi Tanabe Pharma America, Inc. (MTPA) and Soleo Health today announced a virtual poster presentation reviewing the analysis of real-world experience outcomes of treatment with RADICAVA® (edaravone) in people with amyotrophic lateral sclerosis (ALS). The findings were presented as part of the Motor Neurone Disease Association (MNDA) 31st International Symposium on ALS/MND, which is being held virtually December 9-11.
“We are pleased to share this real-world data with the ALS community,” said Atsushi Fujimoto, President, MTPA. “We hope the insights are helpful for the healthcare providers who are considering treatment for those impacted by this debilitating disease.”
The observational, retrospective cohort study included 167 ALS patients with a mean age of 64 years, all under the care of Soleo Health clinicians. De-identified data on these patients was collected through Soleo Health’s clinical outcomes program, SoleMetrics®. Patients included in this analysis were treated with IV edaravone for at least three consecutive months between August 8, 2017 and March 31, 2020. The study was limited to ALS patients receiving treatment through infusion services, so results may not be generalizable to all ALS patients. The study relies on Electronic Health Record (EHR) data and self-reported data.
In the cohort study, reported changes in ALS Functional Rating Scale-Revised (ALSFRS-R) scores were consistent with those observed in the pivotal Phase 3 trial (Study 19) that showed treatment with RADICAVA slowed the loss of physical function over a 24-week period by 33% or 2.49 ALSFRS-R points (p=0.0013) compared to placebo.
By the end of the study period, for the 78 patients (46.7%) who continued treatment and had repeat ALSFRS-R scores, 38.3% had more than 12 months of continuous treatment, and a median treatment duration of 22.6 months. The mean change per month in ALSFRS-R showed for patients of this same cohort was approximately -0.40 +/- 0.52 point per month during the follow-up period (40.5 +/- 7.2 at the start of treatment; 27.6 +/- 11.8 at the last treatment visit). Of the 167 patients, 89 (53.5%) discontinued treatment. Additionally, of the patients that stayed on continuous treatment for 12 months, 25% reported feeling “good” in their overall health and wellness and 66.7% reported feeling “okay.”
“Soleo Health’s ability to collect specific data through its proprietary SoleMetrics patient outcomes program proved valuable in helping to elucidate real-world treatment patterns with IV edaravone in the U.S.,” added Barbara Prosser, RPh., Vice President of Health Economics and Outcomes Research at Soleo Health. “We believe our collaboration with MTPA will have a meaningful impact on the ALS community.”
To gather the data, Soleo Health’s SoleMetrics program monitored patient status over time, as well as response to therapy using the ALSFRS-R scale.
“The rate of progression in ALS can be highly variable, and a change of just one point in several domains of the ALSFRS-R scale can be significant for people with this life-threatening disease,” said Benjamin Brooks, M.D., an ALS specialist and researcher. “As a clinician dedicated to the care of ALS patients, I am grateful to be able to have these real-world results available to me when considering therapies.”
For more information on the poster presentation, click here.
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.
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
For more information, including full Prescribing Information and Patient Information, please visit www.RADICAVA.com.
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.
Overview of Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters in Doshomachi, Osaka, which is the birthplace of Japan’s pharmaceutical industry. With business centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company with one of the longest histories of pharmaceutical companies in Japan.2 In accordance with the corporate philosophy of “contributing to the healthier lives of people around the world through the creation of pharmaceuticals,” the Company formulated the key concept of Open Up the Future under the Medium-Term Management Plan 2016-2020. Through the discovery of drugs that address unmet medical needs, centered on its priority disease areas — immune-inflammation diseases, diabetes and kidney, central nervous system, and vaccines — Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA. For more information, go to https://www.mt-pharma.co.jp/e/.
About Soleo Health
Frisco, Texas-based Soleo Health is an innovative national provider of complex specialty pharmacy and infusion services, administered in the home or at alternate sites of care. Soleo Health’s interdisciplinary team, comprised of experienced clinical pharmacists and registered nurses, utilizes a consistent patient management process, which leads to quantifiable clinical and economic value while improving the patient experience. Soleo Health operates 20 locations throughout the U.S. with national nursing coverage and pharmacy licensure in 50 states and is accredited by The Joint Commission. For more information, visit www.soleohealth.com or connect with Soleo Health on LinkedIn, Facebook, and Twitter.
- RADICAVA® U.S. Prescribing Information. August 2018.
- Research by TOKYO SHOKO RESEARCH, LTD.