Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the two-year launch anniversary of RADICAVA ORS ® (edaravone) in the U.S.
| JERSEY CITY, N.J., June 17, 2024 /PRNewswire/ --Mitsubishi Tanabe Pharma Corporation America, Inc. (MTPA) today announced the two-year launch anniversary of RADICAVA ORS® (edaravone) in the U.S. Since its availability in June 2022, RADICAVA ORS has been used to treat over 9,600 people living with amyotrophic lateral sclerosis (ALS).1
“Helping people who are living with serious and debilitating diseases is our greatest motivator, and we are honored that for two years, RADICAVA ORS has provided people with ALS an oral treatment option,” said Yasutoshi Kawakami, President, MTPA. “We are encouraged by the ongoing research and work being done in the field as we remain dedicated to supporting the ALS community.” Approved by the U.S. Food and Drug Administration (FDA) in May 2022, RADICAVA ORS is an oral formulation that offers the same efficacy as RADICAVA® (edaravone), an intravenous (IV) treatment.2,3 The Phase 3 pivotal clinical trial showed treatment with RADICAVA (n=68) slowed the loss of physical function by 33 percent (approximately one-third) compared to those taking placebo (n=66) at 24 weeks, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R).2,4 Additionally, this year, the FDA recognized seven years of Orphan Drug Exclusivity (ODE) for RADICAVA ORS based on their assessment that the oral formulation constitutes a major contribution to patient care for people living with ALS. To date, more than 2,400 U.S. healthcare providers (HCPs) have prescribed RADICAVA ORS and/or RADICAVA to one or more of their patients, and 82% of people who started RADICAVA ORS treatment in the 20-month period between June 1, 2022 and March 22, 2024 have continued treatment for three months or more.5,6 RADICAVA ORS and RADICAVA are widely distributed by specialty pharmacies across the U.S. and in Puerto Rico. In the past year alone, the real-world impact of RADICAVA was presented through scientific exchange at eight medical congresses including the 22nd Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting and in multiple peer-reviewed, published studies. Most notably, an article in Muscle & Nerve demonstrated that timely and continued treatment with RADICAVA when initiated first suggests a lower risk of death, tracheostomy, permanent assisted ventilation (PAV) or hospitalization, compared to people with ALS who received placebo first followed by RADICAVA. “As a physician who has treated people living with ALS for nearly a half-century, I’m delighted that an oral option like RADICAVA ORS with well-established pharmacodynamic properties providing edaravone blood levels comparable to those obtained with intravenous RADICAVA is available,” said Benjamin Rix Brooks, M.D. “A growing body of evidence, including recent results from an analysis that evaluated real-world data, helps to strengthen RADICAVA’s position as an important treatment option for those with ALS.” The initial treatment cycle starts with daily dosing of RADICAVA ORS for 14 days followed by a 14-day drug-free period. Subsequent treatment cycles include daily dosing 10 out of 14 days followed by a 14-day drug-free period. People taking RADICAVA ORS should use the provided five milliliter syringe that comes with the product and should not use a household teaspoon to measure the medication. RADICAVA ORS should be stored upright at room temperature between 68°F-77°F and protected from light.2 In prior clinical trials for RADICAVA, the most common adverse events (AEs) reported in participants were contusion (15%), gait disturbance (13%) and headache (10%). In the pivotal safety trial for RADICAVA ORS (MT-1186-A01), the most common AEs reported at 24 weeks in participants were muscular weakness (16.2%), fall (15.7%) and fatigue (7.6%). RADICAVA and RADICAVA ORS are contraindicated in people with a history of hypersensitivity to edaravone or any of the inactive ingredients.2 See Important Safety Information below. MTPA continues to support people taking RADICAVA ORS through the JourneyMate Support Program™ and Share Your Story program. The JourneyMate Support Program™ helps to give patients understanding, answers and resources to supplement what their doctor provides. Experienced program team members are trained to address patient educational needs and provide them with personalized answers and resources for living with ALS. For more information, call a JourneyMate Resource Specialist at 1-866-684-7737 or visit RADICAVA.com/journeymate. The Share Your Story program shares the real-life experiences of those living with ALS and why treatment with RADICAVA ORS matters to them. Through the shared experiences of people living with ALS, the program aims to help people who live with the disease feel like they’re part of a larger community of support and understanding, as people in the ALS community have a lot to share – questions and fears, as well as stories of courage and hope. To explore video and written experiences from people with ALS visit, ALSStories.com. About RADICAVA® (edaravone) and RADICAVA ORS® (edaravone) 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. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA and RADICAVA ORS have been used to treat over 16,000 people with ALS, with over 1.9-million days of therapy, and have been prescribed by over 2,400 HCPs.1,5,7 IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves. Sulfite Allergic Reactions Adverse Reactions Pregnancy To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. INDICATION For more information, including full Prescribing Information, please visit www.RADICAVA.com. About JourneyMate Support Program™ About Mitsubishi Tanabe Pharma America, Inc. About Mitsubishi Tanabe Pharma Corporation Media inquiries: 1 Data on file. Mitsubishi Tanabe Pharma America, Inc.
SOURCE Mitsubishi Tanabe Pharma America, Inc. |
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