Biotech Values

[DewDiligence]

Re: Xarelto sNDA for ACS in stented patients

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). Inasmuch as the pending NDA in ACS has a priority review and a PDUFA date in Jun 2012, it’s clearly to JNJ’s advantage for the new ACS/PCI sub-indication to be considered separately; however, it probably makes more sense for the FDA to consider both datasets at the same time.

Comments?

The FDA advisory panel for the sNDA in ACS per se is scheduled for 5/23/12.

JNJ’s own PR on today’s FDA submission:
http://www.jnj.com/connect/news/all/janssen-research-development-submits-supplemental-new-drug-application-to-us-fda-for-xarelto-rivaroxaban-to-reduce-the-risk-of-stent-thrombosis-in-patients