JERSEY
CITY, N.J., June 17,
2024 /PRNewswire/ -- Mitsubishi Tanabe Pharma
America, Inc. (MTPA) today announced the two-year launch
anniversary of RADICAVA ORS® (edaravone) in the U.S.
Since its availability in June 2022,
RADICAVA ORS has been used to treat over 9,600 people living with
amyotrophic lateral sclerosis (ALS).1
"Helping people who are living with serious and debilitating
diseases is our greatest motivator, and we are honored that for two
years, RADICAVA ORS has provided people with ALS an oral treatment
option," said Yasutoshi Kawakami,
President, MTPA. "We are encouraged by the ongoing research and
work being done in the field as we remain dedicated to supporting
the ALS community."
Approved by the U.S. Food and Drug Administration (FDA) in
May 2022, RADICAVA ORS is an oral
formulation that offers the same efficacy as RADICAVA®
(edaravone), an intravenous (IV) treatment.2,3 The
Phase 3 pivotal clinical trial showed treatment with RADICAVA
(n=68) slowed the loss of physical function by 33 percent
(approximately one-third) compared to those taking placebo (n=66)
at 24 weeks, as measured by the ALS Functional Rating Scale-Revised
(ALSFRS-R).2,4 Additionally, this year,
the FDA recognized seven years of Orphan Drug Exclusivity (ODE) for
RADICAVA ORS based on their assessment that the oral formulation
constitutes a major contribution to patient care for people living
with ALS.
To date, more than 2,400 U.S. healthcare providers (HCPs) have
prescribed RADICAVA ORS and/or RADICAVA to one or more of their
patients, and 82% of people who started RADICAVA ORS treatment in
the 20-month period between June 1,
2022 and March 22, 2024 have
continued treatment for three months or
more.5,6 RADICAVA ORS and RADICAVA are widely
distributed by specialty pharmacies across the U.S. and in
Puerto Rico.
In the past year alone, the real-world impact of RADICAVA was
presented through scientific exchange at eight medical congresses
including the 22nd Annual Northeast Amyotrophic Lateral Sclerosis
(NEALS) Meeting and in multiple peer-reviewed, published studies.
Most notably, an article in Muscle &
Nerve demonstrated that timely and continued treatment
with RADICAVA when initiated first suggests a lower risk of death,
tracheostomy, permanent assisted ventilation (PAV) or
hospitalization, compared to people with ALS who received placebo
first followed by RADICAVA.
"As a physician who has treated people living with ALS
for nearly a half-century, I'm delighted that
an oral option like RADICAVA ORS with well-established
pharmacodynamic properties providing edaravone blood levels
comparable to those obtained with intravenous RADICAVA is
available," said Benjamin Rix Brooks, M.D. "A growing body of
evidence, including recent results from an analysis that evaluated
real-world data, helps to strengthen RADICAVA's position as an
important treatment option for those with ALS."
The initial treatment cycle starts with daily dosing of RADICAVA
ORS for 14 days followed by a 14-day drug-free period. Subsequent
treatment cycles include daily dosing 10 out of 14 days followed by
a 14-day drug-free period. People taking RADICAVA ORS should use
the provided five milliliter syringe that comes with the product
and should not use a household teaspoon to measure the medication.
RADICAVA ORS should be stored upright at room temperature between
68°F-77°F and protected from light.2
In prior clinical trials for RADICAVA, the most common adverse
events (AEs) reported in participants were contusion (15%), gait
disturbance (13%) and headache (10%). In the pivotal safety trial
for RADICAVA ORS (MT-1186-A01), the most common AEs reported at 24
weeks in participants were muscular weakness (16.2%), fall (15.7%)
and fatigue (7.6%). RADICAVA and RADICAVA ORS are contraindicated
in people with a history of hypersensitivity to edaravone or any of
the inactive ingredients.2 See Important Safety
Information below.
MTPA continues to support people taking RADICAVA ORS through the
JourneyMate Support Program™ and Share Your
Story program. 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 a JourneyMate Resource
Specialist at 1-866-684-7737 or visit RADICAVA.com/journeymate. The
Share Your Story program shares the real-life
experiences of those living with ALS and why treatment with
RADICAVA ORS matters to them. Through the shared experiences of
people living with ALS, the program aims to help people who live
with the disease feel like they're part of a larger community of
support and understanding, as people in the ALS community have a
lot to share – questions and fears, as well as stories of courage
and hope. To explore video and written experiences from people with
ALS visit, ALSStories.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.2
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.1,5,7
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 an
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 Data on file. Mitsubishi Tanabe Pharma
America, Inc.
2 RADICAVA and RADICAVA ORS Prescribing Information.
Jersey City, NJ: Mitsubishi Tanabe
Pharma America, Inc.; 2022
3 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
4 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.
5 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
6 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
7 Data on file. Mitsubishi Tanabe Pharma America,
Inc.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-celebrates-second-anniversary-of-radicava-ors-edaravone-launch-in-the-us-302173391.html
SOURCE Mitsubishi Tanabe Pharma America, Inc.