Bayer 's ( BAYRY ) HealthCare
segment recently received a positive recommendation from the
European Committee for Medicinal Products for Human Use (CHMP) for
Xarelto (rivaroxaban) in combination with standard antiplatelet
Bayer is looking to get Xarelto's label expanded for the
prevention of atherothrombotic events (myocardial infarction,
cardiovascular death or stroke) after an acute coronary syndrome
(ACS) in adults having elevated cardiac biomarkers.
A final decision from the European Commission on the approval of
the new indication of Xarelto is expected soon. We note that though
the European Commission is not bound to follow the CHMP's decision,
it generally does so.
Xarelto was studied in the phase III ATLAS ACS 2-TIMI 51 study.
Results from the study showed that Xarelto along with standard
antiplatelet therapy significantly reduced cardiovascular death,
myocardial infarction or stroke in patients after an ACS in
comparison to those who received standard antiplatelet therapy
Xarelto is marketed by Johnson & Johnson (
JNJ ) in the US and
by Bayer outside the US.
We note that Xarelto is already approved for several indications
in the US including stroke prevention in nonvalvular atrial
fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE)
and reducing the risk of recurrent DVT and PE. The drug performed
impressively last year. In 2012, Xarelto sales increased 265.9%
year over year to €322 million (approximately $414.1 million).
Earlier this month, Bayer and Johnson & Johnson received a
huge setback with the US Food and Drug Administration (FDA) issuing
a second complete response letter (CRL) for the supplemental New
Drug Application (sNDA) for Xarelto (2.5 mg twice daily) for the
reduction of the risk of secondary cardiovascular events in
patients suffering from ACS.
A second CRL from the US regulatory body is a huge
disappointment for the company. Bayer, a large cap pharma company,
currently carries a Zacks Rank #4 (Sell). Meanwhile other large cap
pharma stocks such as Novo Nordisk ( NVO ) and
AbbVie Inc. ( ABBV ) are better
positioned carrying a Zacks Rank #2 (Buy).ABBVIE INC (ABBV): Free Stock Analysis ReportBAYER A G -ADR (BAYRY): Free Stock Analysis
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