JERSEY
CITY, N.J., July 9, 2024
/PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA)
today announced the presentation of four abstracts in amyotrophic
lateral sclerosis (ALS) at the inaugural ALS Nexus Conference,
being held in Dallas, Texas,
July 14-17, 2024. The presentations
will share results from multiple real-world studies in ALS,
including analyses of treatment with RADICAVA®
(edaravone).
In addition, MTPA will host a program highlighting the clinical
history, efficacy and safety, and real-world experience of RADICAVA
ORS® (edaravone). Dr. Gary
Pattee will present clinical evidence and data behind the
product and will be joined by Gwen
Petersen, a patient advocate, who will share her journey,
including the role RADICAVA ORS has played in her life.
- From Clinical Trials to Real-World Experience
(Gary Pattee, MD Clinical
Neurologist, Bryan Physicians Network and Assistant
Professor, Clinical Instructor Department of Neurology,
University of Nebraska Medical Center
& Gwen Petersen, Patient
Advocate)
12:55 p.m. –
2:00 p.m. CT, July 16
"A complex disease such as ALS requires consistent research and
data-sharing, and we hope that insights from our clinical and
real-world studies of RADICAVA are useful to healthcare providers
in the development of personalized treatment plans," said
Gustavo A. Suarez Zambrano, M.D.,
Vice President of Medical Affairs at MTPA. "We commend the ALS
Association for bringing the entire ALS community together –
including patients – to collaborate at the first ALS Nexus
Conference and drive forward our shared mission in navigating the
challenges of ALS treatment."
Real-World Data
Preliminary results will be presented
evaluating treatment patterns, clinical outcomes and survival of
people living with ALS in the ALS/Motor Neuron Disease (MND)
Natural History Consortium (NHC) registry who have been treated
with RADICAVA. Additionally, a preliminary analysis will be
presented utilizing U.S.-based administrative claims data from
electronic health records found in Optum's Clinformatics Data Mart.
The presentation will highlight demographics, clinical
characteristics and treatment patterns in people with ALS. A
separate preliminary analysis will be presented on healthcare
resource utilization of people living with ALS treated with
RADICAVA ORS® (edaravone).
- Treatment Patterns and Survival Benefit of Edaravone–Treated
People with Amyotrophic Lateral Sclerosis in the ALS/MND Natural
History Consortium (Stephen
Apple, M.D.; MTPA)
Presentation Session A:
4:00 p.m. – 6:00 p.m. CT, July
16
- Preliminary Analysis of Treatment Combinations in Patients
with Amyotrophic Lateral Sclerosis Enrolled in an US-Based
Administrative Claims Database (Malgorzata Ciepielewska, MS;
MTPA)
Presentation Session A: 4:00
p.m. – 6:00 p.m. CT,
July 16
- Preliminary Analysis of Treatment Patterns in Patients with
Amyotrophic Lateral Sclerosis Using Electronic Health Records
(Stephen Apple, M.D.;
MTPA)
Presentation Session A: 4:00 p.m. – 6:00 p.m.
CT, July 16
- Healthcare Resource Utilization of Oral Edaravone–Treated
Patients with Amyotrophic Lateral Sclerosis Enrolled in an US-Based
Administrative Claims Database (Malgorzata Ciepielewska, MS;
MTPA)
Presentation Session A: 4:00
p.m. – 6:00 p.m. CT,
July 16
About RADICAVA® (edaravone) and RADICAVA
ORS® (edaravone)
The U.S. Food and Drug Administration (FDA) approved
RADICAVA® (edaravone) on May
5, 2017, and the oral formulation RADICAVA
ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic
lateral sclerosis (ALS). In 2024, the FDA recognized RADICAVA ORS
with Orphan Drug Exclusivity based on the major contribution to
patient care of the innovative oral formulation. RADICAVA is
administered in 28-day cycles by intravenous (IV) infusion. It
takes 60 minutes to receive each 60 mg dose. For the initial cycle,
the treatment is infused daily for 14 consecutive days, followed by
a two-week drug-free period. All cycles thereafter are infused
daily for 10 days within a 14-day period, followed by a two-week
drug-free period. RADICAVA ORS is taken daily for 14 consecutive
days followed by a 14-day drug-free period for the initial
treatment cycle. For subsequent treatment cycles, RADICAVA ORS is
taken for 10 days within a 14-day period followed by a 14-day
drug-free period. RADICAVA ORS should be taken in the morning
after overnight fasting. Patients should not eat or drink (except
water) within one hour after taking RADICAVA ORS.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. (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.2-4
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 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 (MTPC). It was established by
MTPC to develop and advance our pipeline as well as commercialize
approved pharmaceutical products in North
America. For more information, please visit
www.mt-pharma-america.com or follow us on X (formerly
Twitter), Facebook and LinkedIn.
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,
Osaka, the birthplace of
Japan's pharmaceutical industry.
MCG has positioned health care as its strategic focus in its
management policy, "Forging the future". MTPC sets the MISSION of
"Creating hope for all facing illness". To that end, MTPC is
working on the disease areas of central nervous system,
immuno-inflammation, diabetes and kidney, and cancer. MTPC is
focusing on "precision medicine" to provide drugs with high
treatment satisfaction and additionally 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. For more information, go to
https://www.mt-pharma.co.jp/e/.
Media inquiries:
Media_MTPA@mt-pharma-us.com
1 RADICAVA and RADICAVA ORS Prescribing Information.
Jersey City, NJ: Mitsubishi Tanabe
Pharma America, Inc.; 2022.
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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SOURCE Mitsubishi Tanabe Pharma America