New heart drug approved
June 21, 2011
New heart drug approved
ASTRAZENECA yesterday
announced the TGA approval of its
Brilinta (ticagrelor), which is a new
type of oral anti-platelet
medication to treat patients with
Acute Coronary Syndromes (ACS).
The drug is in a new class called
cyclopentyltriazolopyrimidines
(CPTPs), and is the first treatment
to demonstrate significant
mortality and morbidity benefits
over clopidogrel, which is currently
the most commonly used oral antiplatelet
treatment.
The approval follows data from
the PLATO study of more than
18,000 patients worldwide
(including 82 from Australia) which
showed a 21% reduced risk of
cardiovascular death in those with
heart attacks and unstable angina.
At a briefing yesterday, PLATO
lead clinical investigator Professor
Philip Aylward from Flinders
Medical Centre described Brilinta as
a significant breakthrough, because
the medication has been shown to
be effective across all ACS patients -
regardless of the type of heart
attack and how they have been
treated (stent, bypass or drugs).
Risk reduction occured regardless
of age, weight, gender, medical
history or initial diagnosis, and
there was also no significant
increase in major or life-threatening
bleeding compared to clopidogrel.
One side effect was shortness of
breath but in most patients this
was easily tolerated, with Prof
Aylward saying the new medication
“will change practice in Australia”.
AstraZeneca medical director Dr
Simon Fisher said the costeffectiveness
of Brilinta was “within
the boundaries of many other
drugs currently listed on the PBS.
“We’re confident that PBS listing
will be achieved,” he added.
Pricing and availability for Brilinta
in Australia hasn’t yet been
finalised at this stage.
Brilinta is already registered in 34
countries incl nations in the EU (under
the name Brilique) and Canada,
while FDA approval is pending.
The above article was sent to subscribers in Pharmacy Daily's issue from 21 Jun 11To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 21 Jun 11
