Johnson & Johnson
) Janssen Research and Development unit recently responded to the
complete response letter (CRL) issued by the US Food and Drug
Administration (FDA) for its supplemental new drug application
(sNDA) for blood-thinner Xarelto (2.5 mg twice daily). The company
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).
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ACS refers to a heart disease, which results in the blockage of a
coronary artery via a blood clot. Johnson & Johnson has
co-developed Xarelto with the HealthCare unit of
). The FDA had issued a CRL for the indication in June 2012. The
response includes the information requested by the US regulatory
authority while issuing the CRL.
Furthermore, Bayer/ Johnson & Johnson announced that the sNDA
seeking approval to market Xarelto for reducing the risk of stent
thrombosis in ACS patients has been resubmitted. In July 2012, the
companies withdrew the sNDA for the indication.
We note that Bayer/ Johnson & Johnson are seeking to expand the
label of Xarelto, already approved for multiple indications, into
other indications as well apart from the above two indications.
In July 2012, the companies announced that the FDA will review
their marketing application for Xarelto for treating patients
suffering from deep vein thrombosis (DVT) or pulmonary embolism
(PE) and the prevention of recurrent DVT and PE on a priority
basis. Thrombosis refers to the formation of a blood clot inside a
blood vessel thereby blocking a vein (venous thrombosis) or artery
We note that the US regulatory authority generally reviews those
drugs on a priority basis, which offer major advances in treating
diseases that do not have adequate therapy. Applications for
priority review designated drugs are reviewed by the FDA within six
months of submission as against the usual ten months. The sNDA was
filed on May 2, 2012. Consequently, a response should be out in the
fourth quarter of 2012. Approval of Xarelto for new indications
would further boost the sales potential of the drug.
Currently, we have a Neutral stance on Bayer in the long run. The
company carries a Zacks #3 Rank (Hold rating) in the short run. Our
long-term recommendation is similar on Johnson & Johnson. The
stock carries a Zacks #4 Rank (Sell rating) in the short run.