JERSEY CITY, N.J., April 15, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the presentation of one abstract in amyotrophic lateral sclerosis (ALS) at the Academy of Managed Care Pharmacy (AMCP) 2024 Annual Meeting, being held in New Orleans, La., Apr. 15-18, 2024.
JERSEY CITY, N.J., April 8, 2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that the U.S. Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity (ODE) for RADICAVA ORS® (edaravone) based on their assessment that the oral form of edaravone constitutes a major contribution to patient care for people living with amyotrophic lateral sclerosis (ALS). The FDA's Orphan Drug program is designed to support the development of drugs that treat rare diseases which affect less than 200,000 people in the U.S. Previously, the FDA granted RADICAVA ORS Priority Review and Fast Track designations.
Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced that the US Food and Drug Administration (FDA) has recognized seven years of Orphan Drug Exclusivity (ODE) for Radicava ORS (edaravone) based on their assessment that the oral form of edaravone constitutes a major contribution to patient care for people living with amyotrophic lateral sclerosis (ALS). The FDA’s Orphan Drug programme is designed to support the development of drugs that treat rare diseases which affect less than 200,000 people in the US Previously, the FDA granted Radicava ORS Priority Review and Fast Track designations.
JERSEY CITY, N.J., Aug. 17, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of a post-hoc analysis of the pivotal, Phase 3 study (MCI186-19) reviewing the effect of intravenous (IV) RADICAVA® (edaravone) on survival and additional disease progression milestone events in people with amyotrophic lateral sclerosis (ALS). Results from the analysis, which were published in Muscle & Nerve, suggest that timely and continued treatment with RADICAVA when initiated first was associated with a lower risk of death, tracheostomy, permanent assisted ventilation (PAV) or hospitalization, compared to people with ALS who received placebo first followed by RADICAVA.
FDA Confirms Paragraph IV Patent Litigation for Edaravone Oral Suspension
JERSEY CITY, N.J., June 15, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the one-year launch anniversary of RADICAVA ORS® (edaravone) in the U.S. Since becog available in June 2022, RADICAVA ORS has been used to treat over 5,300 people living with amyotrophic lateral sclerosis (ALS).1
JERSEY CITY, N.J., April 20, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced six presentations in amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD) will be shared as part of the 2023 American Academy of Neurology (AAN) Annual Meeting, being held virtually and in Boston, Mass., April 22-27.
JERSEY CITY, N.J., March 23, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced it has completed enrollment for the global, multi-center, double-blind, Phase 3b study (MT-1186-A02) evaluating the long-term efficacy and safety of two dosing regimens of RADICAVA ORS® (edaravone) in people with amyotrophic lateral sclerosis (ALS) over 48 weeks. This study is the postmarketing commitment following the U.S. Food and Drug Administration (FDA) approval of intravenous (IV) RADICAVA® (edaravone). Topline results of the study are anticipated in 2024.
JERSEY CITY, N.J., March 16, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that more than 10,000 people with amyotrophic lateral sclerosis (ALS) have received treatment with intravenous (IV) RADICAVA® (edaravone) and/or RADICAVA ORS® (edaravone) since the therapies became available in the U.S. in August 2017 and June 2022, respectively.1 To date, more than 2,000 U.S. HCPs have prescribed RADICAVA ORS and/or RADICAVA to one or more of their patients, and 79% of people who started treatment in the six-month period between June 1, 2022 and November 30, 2022 have continued treatment for three months or more through February.2,3 RADICAVA ORS and RADICAVA are widely distributed by specialty pharmacies across the U.S. and in Puerto Rico.
JERSEY CITY, N.J., March 10, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) is proud to announce that as of June 2022, RADICAVA ORS® (edaravone) has been added to the U.S. Department of Veterans Affairs National Formulary (VANF), with a national prior authorization process in place, making the treatment accessible to U.S. veterans living with amyotrophic lateral sclerosis (ALS) who are within the VA's integrated healthcare system.