The HealthCare unit of
) and its partner,
Johnson & Johnson's
) Janssen Research and Development unit, received some
disappointing news recently when an advisory panel of the U.S. Food
and Drug Administration (FDA) recommended against approving their
blood thinner Xarelto for an additional indication.
The partners are looking to get Xarelto approved for the
reduction of the risk of secondary cardiovascular events in
patients suffering from acute coronary syndrome (ACS). The
supplemental new drug application (sNDA) was filed late last year.
ACS refers to a heart disease, which results in the blockage of a
coronary artery via a blood clot. The application is being reviewed
on a priority basis by the FDA, which implies a six-month review
period instead of the usual ten-month period.
The sNDA contains data from the ATLAS ACS 2 TIMI 51 phase III
study which revealed that treatment with Xarelto as a combination
therapy (2.5 mg twice daily) caused a significant reduction in
cardiovascular events such as myocardial infarction or stroke or
even cardiovascular death in recently affected ACS patients
compared to those treated with only the standard antiplatelet
A final decision from the FDA regarding the matter is expected
by June 29, 2012 (target date). Even though the U.S. agency is not
bound to follow the advice of its advisory committee, the
recommendation of the panel is usually considered by the agency
while deciding the fate of a candidate.
Xarelto is already approved for some other indications including
the lucrative stroke prevention in nonvalvular atrial fibrillation
(SPAF) indication. Apart from SPAF, Xarelto is approved for the
treatment of deep vein thrombosis (DVT) in the E.U.DVT refers to
the obstruction of a blood vessel, courtesy a blood clot.
Furthermore, in July 2011, the FDA cleared Xarelto for the
prevention of DVT, which may cause pulmonary embolism in patients
undergoing knee or hip replacement surgery.
We currently have a Neutral recommendation on Bayer in the
long-run. The company carries a Zacks #3 Rank (Hold rating) in the
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