Biotech Values

[DewDiligence]

JNJ pulls Xarelto NDA is PCI sub-indication of ACS:

http://www.jnj.com/connect/news/all/fda-grants-priority-review-for-xarelto-rivaroxaban-supplemental-ndas-for-the-treatment-of-deep-vein-thrombosis-dvt-pulmonary-embolism-pe-and-the-long-term-prevention-of-dvt-pe

Janssen R&D announced it is withdrawing the sNDA for the use of XARELTO® to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome (ACS). The company is withdrawing this sNDA because it is contingent on a separate sNDA, for XARELTO® to reduce of the risk of secondary cardiovascular events in patients with ACS, which Janssen R&D received a complete response letter from the FDA on June 21, 2012.

I questioned the independence of JNJ’s NDA in PCI when it was first announced; from #msg-75391993:

I wonder if the FDA will treat this submission as an entirely separate review or will seek to consolidate it with the pending NDA in ACS, which JNJ submitted in Dec 2011 (#msg-70355845).

The answer was evidently the latter.

JNJ’s PR referenced above made the headline item the FDA’s granting of a priority review for the separate Xarelto NDA in treatment and secondary prevention of VTE. This suggests that JNJ already knew about the withdrawal of the Xarelto NDA in PCI and was waiting for an opportunity to cover the bad news in a PR about something positive. Pretty sleazy behavior, IMO.

The PDUFA date for the Xarelto NDA in VTE treatment/secondary prevention should be on or about 11/2/12.