) Healthcare unit recently 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). Bayer is looking to get
Xarelto's label expanded for the reduction of the risk of
secondary cardiovascular events in patients suffering from acute
coronary syndrome (ACS).
Xarelto is marketed by
Johnson & Johnson
) in the US and by Bayer outside the US. Bayer is currently
evaluating the CRL with Johnson & Johnson and intends to
respond to the US regulatory authority soon.
We note that in Sep 2012, Johnson & Johnson had
resubmitted the sNDA for blood-thinner Xarelto. The initial CRL
for the indication was issued in Jun 2012.
Bayer's sNDA submission was based on encouraging data from a
global late-stage study (ATLAS ACS 2-TIMI 51). Results from the
study revealed that there was a significant reduction in
cardiovascular events in patients treated with a combination of
Xarelto (2.5 mg twice daily) and standard antiplatelet therapy
versus those treated only with standard antiplatelet therapy.
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
Bayer currently carries a Zacks Rank #3 (Hold). Meanwhile
other pharma stocks such as
Eli Lilly and Company
) carry a Zacks Rank #2 (Buy).
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