JERSEY
CITY, N.J., May 23, 2024
/PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA)
is aware of recent external challenges facing the amyotrophic
lateral sclerosis (ALS) treatment landscape. We know firsthand the
great need for ALS treatments and when there is a setback for one
of us, the entire community is affected.
We want to reiterate that we remain focused on our mission to
support the broader community through research, treatments,
advocacy and patient resources.
We are dedicated to advancing our understanding of ALS through
ongoing research, including continuing to evaluate the full
potential of FDA-approved RADICAVA ORS® (edaravone) and
intravenous (IV) RADICAVA® (edaravone). The U.S.
approval of RADICAVA IV was based on Study 19 (MCI186-19), a
randomized placebo-controlled Phase 3 study which was conducted
prospectively in 137 people who met criteria identified from an
exploratory analysis of the Phase 3 MCI186-16 study. In Study 19,
on average, patients on RADICAVA® lost 2.49 fewer points
on the ALSFRS-R vs those in the placebo arm
(p=0.0013).1
RADICAVA ORS® offers the same drug as RADICAVA
IV® in a different formulation.1,2 RADICAVA
IV and RADICAVA ORS help slow the loss of physical function in
patients with ALS by 33 percent vs. placebo, measured over 24-weeks
by the ALS Functional Rating Scale-Revised
(ALSFRS-R).1,2 The safety profile of RADICAVA IV was
demonstrated in pooled placebo-controlled trials in which 184
patients with ALS were administered RADICAVA IV (60 mg) in 24-week
treatment cycles.1 The safety profile of RADICAVA ORS
was demonstrated in a 6-month, Phase 3, open-label clinical trial
in 185 patients.1 In addition to contusion, gait
disturbance, and headache reported with RADICAVA, fatigue was
observed in 7.6% (14/185) of patients receiving RADICAVA
ORS®.1 Please see Important Safety
Information below and Full Prescribing Information here.
Over the past years, we have conducted real-world evidence (RWE)
studies* to evaluate RADICAVA IV-treated ALS patients with
non-RADICAVA patients.1 We are also gathering data on
related factors, including healthcare resource utilization and
patient outcomes. We believe the data gathered from RWE underscores
our commitment to transparency and evidence-based practices.
To date, in the U.S., RADICAVA IV and RADICAVA ORS have been
used to treat over 14,600 people with ALS, with over 1.8-million
days of therapy, and have been prescribed by more than 2,300
HCPs.4-6 RADICAVA ORS and RADICAVA IV have been
supported by a robust set of data from multiple MTPA-sponsored
clinical trials, post-hoc analysis and RWE studies evaluating the
efficacy and safety. These results have been published in over 40
peer-reviewed articles.
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. In the U.S., RADICAVA and RADICAVA ORS are available
via MTPA's network of specialty pharmacies and specialty
distributors.
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
* These studies are limited only to patients with ALS who have
commercial health coverage. Real-world data analyses have inherent
limitations and are not intended to replace prospective clinical
trials.
1 RADICAVA and RADICAVA ORS Prescribing Information.
Jersey City, NJ: Mitsubishi Tanabe
Pharma America, Inc.; 2022.
2 Shimizu H, et al. Bioequivalence study of oral
suspension and intravenous formulation of edaravone in healthy
adult subjects. Clin Pharmacol Drug Dev.
2021;10(10):1188-1197.
3 Brooks, B, et al. Intravenous edaravone treatment in
ALS and survival: An exploratory, retrospective, administrative
claims analysis. eClinicalMedicine. 2022; 52: 101590.
4 Data on file, MTPA.
5 Data on file, MTPA.
6 Data on file, MTPA.
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SOURCE Mitsubishi Tanabe Pharma America