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FDA approves natalizumab (Tysabri®
- formerly known as Antegren) for relapsing forms of MS
Summary
On November 23, 2004, the US Food and Drug Administration (FDA)
approved natalizumab (Tysabri®, formerly known
as Antegren) as a treatment for relapsing forms of MS, creating
another treatment option in the United States. (Tysabri is
pronounced tie-SAB-bree.)
Tysabri is currently under priority review by Health Canada
with a decision anticipated in 2005. The MS Society of Canada
is closely monitoring the therapy’s review status.
Details
The FDA approval was based on results from the first
year of two ongoing clinical trials of the drug alone compared
to placebo (inactive treatment) or added to beta interferon-1a
(Avonex®).
Tysabri reduced the rate of clinical relapses
(MS attacks) by up to 66% and reduced the development of new
or newly enlarging MRI-detected brain lesions. A greater proportion
of those on therapy remained relapse-free compared to the placebo
groups.
Tysabri appears to be safe and well tolerated;
the most common side effects included headache, fatigue, urinary
tract infection, depression, lower respiratory tract infection,
joint pain and abdominal discomfort. There is no information
available about long-term safety or its relative benefits or
safety in comparison with other currently available treatments
for MS.
The drug is given by monthly intravenous
(into the vein) infusions in a doctor’s office.
In the United States, the wholesale price
of Tysabri has been announced to be $1,808 per vial or dose,
which would be $23,504 (US) per year if taken every four weeks.
The Canadian price will not be established until it is approved
by Health Canada.
(With information courtesy, National
MS Society [USA])
Biogen Idec Canada has made available an information line in
English and French for further inquiries about Tysabri (natalizumab):
1-877-674-6365.
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Disclaimer
The Multiple Sclerosis Society of Canada is an independent,
voluntary health agency and does not approve, endorse or
recommend any specific product or therapy but provides information
to assist individuals in making their own decisions.
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