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Bayer’s (BAYRY - Analyst Report) 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 (JNJ - Analyst Report) 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 $414.1 million).
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