MS drug breakthrough
September 20, 2010
THE first-ever tablet treatment for
people living with multiple sclerosis,
Movectro (cladribine), has received
Therapeutic Goods Administration
approval.
Indicated for use in the treatment
of relapsing-remitting MS for a
maximum duration of two years,
Movectro is the world’s first short
course MS treatment, and as such
patients need only to take the drug
for around two weeks each year.
This short course treatment could
potentially see many patients switch
from regular infusions and daily
treatment injections.
Movectro’s approval follows the
release of results from a 96 week
randomised, double-blind, placebo
controlled, international study
which assessed the safety and
clinical efficacy of the cladribine
tablets in 1,326 relapsing-remitting
MS patients in comparison to a
placebo.
The Phase III trial was the largest
of its kind to date and involved
participants from 155 centres
across 32 countries.
Results of the trial found that a
two-week course of Movectro per
annum provided “a significant
benefit for patients with relapsing–
remitting multiple sclerosis with
respect to the rate of relapse,
disability progression, and MRI
measures of disease activity”.
“It is exciting that not only have
we had successful phase three trials
for the first two oral treatments of
MS, of which Movectro is one, but
that the first of the regulatory steps
to make these medications
available to people with MS has
been passed by Movectro,” said
Professor Bill Carroll, Chair of MS
Research Australia.
“Movectro adds to the range of
choices available for the treatment
of multiple sclerosis, which is
essential as there are a number of
types of MS and people are in
different stages of the disease
needing new treatment options,”
Carroll added.
At present the drug’s
manufacturer, Merck Serono, is
working with reimbursement
authorities in a bid to get Movectro
listed on the PBS, and has said that
it will release details around private
market access in Australia “when
when necessary administrative and
regulatory steps have concluded”.
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