JERSEY
CITY, N.J., April 29,
2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma
America, Inc. (MTPA) is celebrating its eight-year anniversary of
being established in the United
States (U.S.). In 2016, MTPA was created as a wholly-owned
subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), with the
goal of developing and advancing the company's pipeline in the U.S.
while focusing on improving research in the areas of amyotrophic
lateral sclerosis (ALS), erythropoietic protoporphyria (EPP),
Parkinson's disease, spinal cord injury and systemic sclerosis.
"For almost a decade, MTPA has been dedicated to advancing
science and research to support underserved patient populations
with complex needs including neurodegenerative diseases,
inflammatory, and metabolic conditions," said Yasutoshi Kawakami, President, MTPA. "We're
proud to continue the 300-year legacy of our parent company, MTPC
in Japan, here in the U.S., where
more than 5,000 people each year are diagnosed with
ALS.1 We are excited to pursue promising medical
advances as we seek new therapies for people struggling with
debilitating diseases."
Over the past eight years, MTPA has achieved success with
RADICAVA® (edaravone) and RADICAVA ORS®
(edaravone), the intravenous (IV) and oral formulations of its
treatment for ALS.
To date, more than 14,600 people with ALS in the U.S. have
received treatment with RADICAVA and/or RADICAVA ORS since the
therapies became available in August
2017 and June 2022,
respectively. The treatments have been prescribed by over 2,300
healthcare professionals (HCPs) and about 80% of RADICAVA and/or
RADICAVA ORS treated patients remain in therapy after three
months.2,3 The FDA recently recognized seven years
of Orphan Drug Exclusivity (ODE) for RADICAVA ORS based on their
assessment that the oral form of edaravone constitutes a major
contribution to patient care for people living with ALS.
The US approval of edaravone was based on Study 19 (or
MCI186-19), a randomized placebo-controlled, pivotal Phase 3 study,
which was conducted prospectively in 137 people who met criteria
identified from an exploratory analysis of the previously conducted
Phase 3 MCI186-16 study. The study was shown to slow the loss of
physical function by 33 percent in 68 patients vs placebo (n=66
patients), measured over a 24-week time period by the ALSFRS-R. On
average, patients on RADICAVA® IV lost 2.49 fewer points on the
ALSFRS-R compared with those in the placebo arm. RADICAVA ORS®
offers the same efficacy as RADICAVA® IV in an oral
formulation.4 Bioequivalence of the IV formulation and
oral suspension were proven in a Phase 1 open-label study
(MT-1186-J03) in 2021.5 The safety profile of the IV
formulation of RADICAVA® was evaluated in multiple
placebo-controlled studies in 184 patients with ALS. The RADICAVA
ORS safety profile was demonstrated in a 6-month clinical study of
185 patients with ALS. The most common side effects were bruising
(contusion) [15%], problems with walking (gait disturbance) [13%],
and headache [10%]. Fatigue was also reported in 7.6% of patients
taking RADICAVA ORS®.4
Last November, MTPA was honored to receive the ALS United
Greater New York Chapter's Jacob K. Javits Lifetime Achievement
Award for groundbreaking work to bring forward a treatment for the
ALS community and pave the way for future therapies. MTPA looks to
continue this work not only through scientific advancements, but by
continuing to support patient advocacy initiatives, including the
sponsorship of ALS Walks and community events, along with a
sponsorship of Parkinson's Awareness Month in April for the
Parkinson's Foundation.
Furthermore, as a part of MTPA's commitment to helping people
with ALS access RADICAVA and RADICAVA ORS, MTPA created the
JourneyMate Support Program™, which provides
educational resources to help patients and caregivers on their ALS
treatment journey.
The JourneyMate Support Program™ helps to give
patients understanding, answers, and resources to supplement what
their doctor provides. Experienced program team members are trained
to address patient educational needs and provide them with
personalized answers and resources for living with ALS. For more
information, call 1-866-684-7737 or visit LetsTalkALS.com.
Additionally, MTPA's Share Your Story
program empowers people with ALS and their caregivers to
express their real-life experiences with this rare disease through
videos and written stories. For more information, visit
ShareYourALSStory.com.
Nearly one year ago, Mitsubishi Tanabe Pharma Holdings America,
Inc. (MTHA) and their development entity, Mitsubishi Tanabe Pharma
Development America, Inc. (MTDA), merged into MTPA. "As our company
continues to advance our late-stage pipeline, we celebrate this
recent integration as it has enabled us to continue to drive
discovery and development," said Bijan Nejadnik, Head of Global
Development and Regulatory Affairs.
Always looking to the future, MTPA continues to further
research in a number of key areas, including Parkinson's disease,
EPP and spinal cord injury, among others. For more information,
visit www.mtpa.com.
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 14,600
people with ALS, with over 1.7-million days of therapy, and have
been prescribed by over 2,300 HCPs.2,3,6
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 JourneyMate Support
Program™
The JourneyMate Support
Program™ offers educational support and resources for
patients who are considering or have already been prescribed an
MTPA product. An ALS Clinical Educator is an educational resource
for patients who have been prescribed a Mitsubishi Tanabe Pharma
America, Inc. (MTPA) product. An ALS Clinical Educator is provided
by MTPA and VMS and is not affiliated with or provided by a doctor.
An ALS Clinical Educator does not provide medical advice. The
program does not provide medical advice and does not take the place
of a patient's doctor. All questions about a condition, diagnosis,
or treatment should be referred to the patient's doctor. If a
patient has a medical emergency, they should call 911. Adverse
events or product complaints should be reported by calling
1-888-292-0058.
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 Mehta P, Kaye W, Bryan L, et al. Prevalence of
Amyotrophic Lateral Sclerosis in the
United States using established and novel methodologies,
2017 Amyotroph Lateral Scler Frontotemporal Degener. 2023
Feb;24(1-2):108-116.
2 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
3 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
4 RADICAVA and RADICAVA ORS Prescribing Information.
Jersey City, NJ: Mitsubishi Tanabe
Pharma America, Inc.; 2022.
5 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.
6 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
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SOURCE Mitsubishi Tanabe Pharma America