Pfizer (
PFE
) has received a major boost as its blockbuster potential blood
thinner drug Eliquis has received coveted U.S. FDA nod for patients
with atrial fibrillation, which is not caused by a heart valve
problem. The much anticipated approval adds to recent positive
developments around the drug and will open much larger U.S. market
that has evaded the drug until now. Last week, the drug secured
Japan's approval for expanding the use to non-valvular atrial
fibrillation or NVAF (irregular heart beat) patients. Eliquis had
already received European Medicines Agency's (EMA) approval for the
similar indication last month (Read
Pfizer Update: Europe Approves Eliquis For Atrial Fibrillation
).
See our complete analysis for Pfizer
Eliquis (Apixaban) is a drug used in blood thinning and is part of
the antithrombotic family, which helps prevent clotting that can
restrict blood circulation to the organs. Along with aforementioned
approvals, Eliquis is already approved in many countries (excluding
the U.S.) for preventing blood clots in patients who have knee or
hip replacements. The FDA, which has turned down the drug two times
earlier, was expected to take a decision on Eliquis by March 2013.
However, an early approval will help the drug take on its closest
rivals Johnson & Johnson's (
JNJ
) Xarelto and Boehringer-Ingelheim's Pradax, which have already
been approved for atrial fibrillation patients.
This however, is only a halfway for Eliquis, which is
expected to garner as much as $3 billion in peak sales. The drug
will not be able to achieve its full sales potential without its
extension to treatment for VTE and acute coronary syndrome (related
to the blockage of coronary arteries), which affects millions of
patients worldwide each year. We, however, see recent impressive
clinical results as a positive sign for approval. Last month,
Eliquis, when compared with a placebo, managed to significantly
reduce blood clots risks in patients suffering from venous
thromboembolism or VTE (a blood clot within a vein).
But, the timing of these pending approvals will matter as
J&J has already resubmitted clinical trials data in a bid to
convince the U.S. FDA to approve the expanded use
of Xarelto by acute coronary syndrome patients (to prevent
heart attack and stroke in patients who have previously had severe
chest pain or heart attack). However once approved for other
indications, we expect Eliquis sales to see strong rise as it has
exhibited significant safety over warfarin and aspirin (ARISTOTLE
and AVERROES trials) in reducing the risk of stroke, and dangerous
blood clots without a major bleeding amongst all non-warfarin
drugs, including Xarelto and Pradax. Bleeding is a major side
effect of blood thinning drugs, sometimes leading to death. Side
effects are one of the biggest factors determining a drug's future.
Pfizer's strong cardiovascular marketing force (Lipitor) will also
come handy in pushing the drug.
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