Aubagio is
Approved by the Australian TGA to Treat Relapsing Forms of MS
It
was announced by Genzyme, a Sanofi company, that the Australian
Therapeutic Goods Administration (TGA) has approved Aubagio
(teriflunomide) 14 mg as a new once daily oral treatment indicated
for patients with relapsing forms of MS.
With
the approval by the TGA, Australia has become the second country to
authorize the prescribing of Aubagio 14 mg by health professionals,
following FDA approval in September.
“We
are very pleased with the TGA approval of Aubagio that makes
available a new option for healthcare professionals, and people
living with MS in Australia who may benefit from this once-daily,
oral treatment,”
said Bill Sibold, Head of Multiple Sclerosis, Genzyme. “The
availability of Aubagio in the U.S. And subsequent registration in
Australia not only demonstrates our continued progress, it also
reflects our commitment to deliver differentiated treatments and
provide access for patients globally.”
The
safety and efficacy data from the TEMSO (Teriflunomide Multiple
Sclerosis Oral) trial was the basis for the TGA's approval of
Aubagio. More than 5,000 patients in 36 countries, including
Australia, are involved in the ongoing clinical development program,
making it amongst the largest of any MS therapy. Some patients in
extension trials have been treated for up to 10 years.
“For
some people living with MS, the additional burden of injectable
therapies administered daily to weekly can sometimes be a struggle,”
said
Associate Professor John King, Senior Neurologist, Royal Melbourne
Hospital, who participated in the clinical trials for Aubagio. “It
is exciting to see a new oral treatment that has been shown to both
reduce relapses and slow the progression of disability. This is an
encouraging development for the MS community.”
Aubagio
is an immunomodulator with anti-inflammatory properties. Although it
is not fully understood how the exact mechanism of action for Aubagio
works, it may involve a reduction in the number of activated
lymphocytes in the central nervous system (CNS).
“We
welcome the advent of a new oral treatment option for MS patients in
Australia,” said
Professor Bill Carroll, Chairman of MS Research Australia. “It
is important for people with MS and their clinicians to have access
to a range of well-tolerated and convenient therapies that may reduce
the impact of the disease on their lives and suit their lifestyle.”
Aubagio
is now marketed in Australia as well as the U.S. Marketing
applications for Aubagio are under review by the European Medicines
Agency (EMA) and other regulatory authorities.
Source:
News-Medical.Net (22/11/12)
Original
Story: Australian TGA approves Aubagio to treat relapsing forms of MS
msrc.co.uk
Multiple Sclerosis Resource Centre
Author:
William D.
