Aussie drug OK for Europe
October 25, 2011
AUSTRALIAN-developed cystic
fibrosis treatment Bronchitol has
been given a positive assessment
by the European Committee for
Medicinal Products for Human Use,
with the move “clearing the way for
the product to be used in Europe”.
Manufactured by Pharmaxis, the
company said it expects the
opinion to be confirmed by the
European Commission, with a
marketing authorisation for
Bronchitol to be granted by January.
Bronchitol will be indicated “for
the treatment of cystic fibrosis in
adults as an add-on therapy to best
standard of care,” with Pharmaxis
ceo Alan Robertson saying the
approval was good news for the
cystic fibrosis community “which
has supported us throughout the
development of Bronchitol.
“Bronchitol is a drug which was
discovered and developed in
Australia,” he said, with the EU OK
representing “the culmination of a
great deal of work by many people.”
Robertson said supply and
logistics arrangements for Europe
had already been established with
Pharmaxis’ marketing partner
Quintiles, while Bronchitol clinical
data had been made known to CF
clinicians in recent publications and
scientific conferences.
Bronchitol will be the first
approved therapy in Europe to
increase mucociliary clearance, a
mechanism of action which has
been shown to improve lung
function and reduce exacerbations.
Currently approved in Australia
for patients aged 18 and above,
Bronchitol will also be part of an
upcoming short clinical trial in
children aged 6-17 “with a view to
extending the licence to this age
group,” the company said.
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