Biotech Values

[DewDiligence]

JNJ submits Xarelto NDA for treatment and secondary prevention of VTE:

http://finance.yahoo.com/news/janssen-research-development-submits-xarelto-130000593.html

Venous thromboembolism (VTE) is a composite of deep vein thrombosis (DVT) and pulmonary embolism (PE), although the PE portion often gets short shrift in clinical studies. JNJ, however, ran a study called EISSTEIN-PE especially for patients for symptomatic PE (#msg-73685353). Along with the phase-3 EINSTEIN-DVT study, which finished two years ago (#msg-53887547), JNJ now has enough data to seek approval for the dual indications mentioned in the header of this post.

In the EU, Xarelto is approved for acute VTE treatment (#msg-67357050—chase the embedded link), but not specifically for secondary prevention of VTE.

In both the US and EU, Xarelto is approved for primary prevention of VTE following hip/knee surgery.

(In the Lovenox competitive analysis in #msg-69173426, the indications for which JNJ is seeking FDA approval are the ones in paragraph C and paragraph D.)