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Die US-Arzneimittel Behörde FDA veröffentlichte
die Zulassung des ALS-Medikaments
Radicava (edaravone)
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Release FDA approves drug to treat ALS
The U.S. Food and Drug Administration today approved
Radicava (edaravone) to treat patients with amyotrophic
lateral sclerosis (ALS), commonly referred to as Lou
Gehrig’s disease. “After learning about the use of edaravone
to treat ALS in Japan, we rapidly engaged with the drug
developer about filing a marketing application in the United
States,” said Eric Bastings, M.D., deputy director of the
Division of Neurology Products in the FDA’s Center for Drug
Evaluation and Research. “This is the first new treatment
approved by the FDA for ALS in many years, and we are
pleased that people with ALS will now have an additional
option.”
ALS is a rare disease that attacks and kills the nerve
cells that control voluntary muscles. Voluntary muscles
produce movements such as chewing, walking, breathing and
talking.
The nerves lose the ability to activate specific
muscles, which causes the muscles to become weak and leads
to paralysis. ALS is progressive, meaning it gets worse over
time. The Centers for Disease Control and Prevention
estimates that approximately
12,000-15,000 Americans have ALS. Most people with ALS
die from respiratory failure, usually within three to five
years from when the symptoms first appear. Radicava is an
intravenous infusion given by a health care professional. It
is administered with an initial treatment cycle of daily
dosing for 14 days, followed by a 14-day drug-free period.
Subsequent treatment cycles consist of dosing on 10 of 14
days, followed by 14 days drug-free. The efficacy of
edaravone for the treatment of ALS was demonstrated in a
six-month clinical trial conducted in Japan. In the trial,
137 participants were randomized to receive edaravone or
placebo.
At Week 24, individuals receiving edaravone declined
less on a clinical assessment of daily functioning compared
to those receiving a placebo. The most common adverse
reactions reported by clinical trial participants receiving
edaravone were bruising (contusion) and gait disturbance.
Radicava is also associated with serious risks that require
immediate medical care, such as hives, swelling, or
shortness of breath, and allergic reactions to sodium
bisulfite, an ingredient in the drug. Sodium bisulfite may
cause anaphylactic symptoms that can be life-threatening in
people with sulfite sensitivity. The FDA granted this drug
orphan drug designation, which provides incentives to
assist and encourage the development of drugs for rare
diseases.
The FDA granted approval of Radicava to Mitsubishi
Tanabe Pharma America, Inc. The FDA, an agency within the
U.S. Department of Health and Human Services, protects the
public health by assuring the safety, effectiveness,
security of human and veterinary drugs, vaccines and other
biological products for human use, and medical devices. The
agency is also responsible for the safety and security of
our nation’s food supply, cosmetics, dietary supplements,
products that give off electronic radiation, and for
regulating tobacco products.
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Quelle: Presseinformation FDA, Mai 2017
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