Aubagio thumbs up
March 25, 2013
THE European Medicine Agency’s
Committee for Medicinal Products
for Human Use (CHMP) has
adopted a positive opinion,
recommending the granting of a
marketing authorisation for Sanofi-
Aventis Aubagio 14 mg film-coated
tablet intended for the treatment
of multiple sclerosis.
The Committee also concluded
that the active substance contained
in Aubagio, teriflunomide, could
not be considered to be a new
active substance.
Teriflunomide is a selective
immunosuppressant (L04AA31)
with anti-inflammatory properties.
The exact mechanism by which
teriflunomide exerts its therapeutic
effect in MS is not fully understood,
but it is known to reduce the
proliferation of lymphocytes by
blocking the mitochondrial enzyme
dihydroorotate dehydrogenase
(DHO-DH).
The benefit with Aubagio is its
ability to reduce the relapse rate in
patients with relapsing remitting MS.
Side effects include upper
respiratory tract infections, urinary
tract infections, diarrhoea, nausea,
paraesthesia, alopecia and increase
in the liver enzyme alanine
aminotransferase.
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