Investing.com
Published Apr 12, 2024 09:14
"We are honored to attend this year's AAN conference, where we will present our latest research in ALS and PD, including new data from Phase 2 and Phase 3 analyses of investigational ND0612 in PD," said
PD data to be presented at the meeting includes:
Investigational ND0612
Presentations include new data from a subgroup analysis from the pivotal Phase 3 BouNDless trial (NCT04006210) evaluating the efficacy and safety of investigational ND0612 in different subgroups of people with PD experiencing motor fluctuations, in addition to findings characterizing infusion site reactions (ISR) reported from treatment with ND0612 in clinical studies. Data from the BouNDless subgroup analysis will be presented orally during a Scientific Platform Session at the meeting. Additional presentations include a post-hoc analysis from the 28-day open-label Study 006 evaluating ND0612 efficacy onset data and findings from a responder analysis of the ongoing Phase 2b BeyoND long-term safety study (NCT02726386) assessing efficacy data for ND0612 in reducing OFF time in people with PD with motor fluctuations.
ALS data to be presented at the meeting includes:
RADICAVA ORS ® (edaravone)
A preliminary analysis of demographics and clinical characteristics in people with ALS being treated with RADICAVA ORS, utilizing
Additional Real-World Data
Additionally, initial results will be presented from a study sponsored by Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) based on data from the Canadian MTP-Patient Support ® program. The study will provide insight into real-world demographics and characteristics of people with ALS treated with RADICAVA. Separately, updates from a prospective study evaluating slow vital capacity in erect-seated and supine positions using in-clinic conventional and in-home, portable spirometry will be presented.
About RADICAVA ® (edaravone) and RADICAVA ORS ® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA ® (edaravone) on
Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA.
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
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
Adverse Reactions
The most common adverse reactions ( ‰¥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Pregnancy
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.
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
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
For more information, including full Prescribing Information, please visit www.RADICAVA.com.
About ND0612
ND0612 is an investigational drug-device combination therapy “ a 24-hours/day, continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson's disease (PD). Development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). The safety and efficacy of ND0612 in PD is under review by the U.S. Food and Drug Administration (FDA), who has assigned a Prescription Drug User Fee Act (PDUFA) target action date for the second quarter of CY (calendar year) 2024.
About Mitsubishi Tanabe Pharma America, Inc.
Based in
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi,
About NeuroDerm, Ltd.
NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in¯Israel, inspired to reduce disease burden and improve the quality of life¯of patients and their families through innovative¯drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at¯www.neuroderm.com¯or follow the Company on¯LinkedIn .
Media inquiries:
Media_MTPA@mt-pharma-us.com
1 RADICAVA and RADICAVA ORS Prescribing Information.
2 Data on file. Mitsubishi Tanabe Pharma America, Inc.
3 Data on file. Mitsubishi Tanabe Pharma America, Inc.
4 Data on file. Mitsubishi Tanabe Pharma America, Inc.
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