JERSEY
CITY, N.J., June 17,
2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma
America, Inc. (MTPA) today announced the presentation of final
results from the global, multi-center, double-blind, Phase
3b MT-1186-A02 study of oral
edaravone in amyotrophic lateral sclerosis (ALS). Final results
showed the daily dosing regimen of RADICAVA ORS®
(edaravone) did not show superiority to the U.S. Food and Drug
Administration (FDA) approved on/off dosing regimen based on the
primary endpoint of Combined Assessment of Function and Survival
(CAFS) at 48 weeks. Both dosing regimens provided comparable change
in ALSFRS-R from baseline to week 48. These findings suggest that
the current on/off regimen of RADICAVA ORS is the most appropriate
regimen for people living with ALS based on efficacy and safety
findings from studies MT-1186-A02 and MCI186-19. ALSFRS-R changes
observed at week 48 in Study MT-1186-A02 of RADICAVA ORS were
similar to the post hoc assessment of the previous Japanese, Phase
3 Study MCI186-19 of intravenous (IV) RADICAVA®
(edaravone).1,2 The MT-1186-A02 study
found no new safety concerns and reinforces edaravone as a safe
product. The full results are included in a poster presentation at
the European Network for a Cure for ALS (ENCALS) 2024 meeting
taking place in Stockholm,
Sweden.
"The safety and efficacy of the on/off dosing regimen of oral
edaravone in this Phase 3b
post-marketing study was similar to the safety and efficacy of oral
edaravone," said Gustavo A. Suarez
Zambrano, M.D., Vice President of Medical Affairs at MTPA.
"We extend our gratitude to the study participants, investigators,
caregivers and clinical trial staff for completing this journey
with us."
The MT-1186-A02 study, which was a post-marketing commitment
following the FDA approval of intravenous (IV) RADICAVA®
(edaravone), was designed to evaluate the superiority of an
investigational once-daily dosing regimen of oral edaravone (105
mg) vs. the FDA-approved on/off dosing regimen administered in
28-day cycles, in people with ALS over 48 weeks. A pre-planned
futility analysis, conducted after 50% of the planned study
population (N=190) reached 48 weeks, assessed the study's primary
endpoint and the probability of the study results changing if all
participants completed the 48-week study period. Through that
interim analysis, the Independent Data Monitoring Committee (IDMC)
concluded that there is a low statistical probability for the
investigational once-daily dosing regimen to show superiority to
the current on/off dosing regimen as measured by the ALS Functional
Rating Scale Revised (ALSFRS-R) score at study completion;
therefore, study discontinuation was recommended by the IDMC.
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.3
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.4-6
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 Edaravone (MCI-186) ALS 19 Study Group. Safety
and efficacy of edaravone in well defined patients with amyotrophic
lateral sclerosis: a randomised, double-blind, placebo-controlled
trial. Lancet Neurol. 2017;16(7):505-512.
3 RADICAVA and RADICAVA ORS Prescribing Information.
Jersey City, NJ: Mitsubishi Tanabe
Pharma America, Inc.; 2022.
4 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
5 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
6 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
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