Anti-clotting drugs:

FDA APPROVES BRILINTA, A NEW
BLOOD THINNER FROM
ASTRAZENECA
In July 2011 the FDA has approved
AstraZeneca's  blood thinner Brilinta
(ticagrelor) for acute coronary
syndromes.

The approval comes with a boxed
warning, however, stating that use of
ticagrelor with aspirin doses above 100
mg/day decreases the effectiveness of
the medication.

Brilinta is designed to keep blood
platelets from sticking together in order
to prevent blood clots that can lead to
heart attacks and strokes. It was
approved for patients diagnosed with
acute coronary syndrome. The product
will compete with the market-leading
anticlotting drug Plavix, marketed by
Sanofi-Aventis SA and Bristol-Myers
Squibb. Plavix is the second
best-selling drug globally after Pfizer
Inc.'s Lipitor with $8.8 billion in sales
last year.

The main international clinical study
AstraZeneca submitted to the FDA in
support of approval compared Brilinta
to Plavix in 18,624 patients in 43
countries who were being treated for a
blocked artery or heart attack. The
results showed Brilinta reduced the
combination of heart attacks, strokes
and death from cardiovascular causes
by 16% compared with Plavix after
patients were treated for a year. All
patients received aspirin. But the FDA
said when looking only at U.S. patients,
they had "worse results" with Brilinta,
which the agency said could have
been related to a higher aspirin dose.

In approving Brilinta on Wednesday,
FDA said clinical trials showed the
drug "was more effective than Plavix in
preventing heart attacks and death,
but that advantage was seen with
aspirin maintenance doses of 75 to
100 milligrams once daily."
Brilinta is sold under the brand name
Brilique outside the U.S.



OTHER DEVELOPMENTS
Otamixaban by SanofiAventis in Phase
2, competing with heparin;

Pradaxa by Boehringer Ingelheim
competing with warfarin; Brilinta by
AstraZeneca competing with Plavix;

Current blockbuster drugs: Bristol
Myers' Plavix, Ono Pharmaceuticals in
Japan, with a drug called Limaprost,  
marketed as Opalmon;

Potential blockbuster: Eli Lilly & Co.
with its Effient;