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DewDiligence

07/17/18 6:27 PM

#220081 RE: DewDiligence #213824

JNJ/GILD—FDA approves Symtuza—an FDC of JNJ’s Prezista and GILD’s TAF/Emtriva/Cobicistat (a/k/a D/C/F/TAF):

https://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-symtuza-dcftaf-the-first-and-only-complete-darunavir-based-single-tablet-regimen-for-the-treatment-of-hiv-1-infection-300682550.html

Symtuza was approved in the EU in Sep 2017 (#msg-134910996).

By prior agreement with GILD (#msg-109435833), JNJ controls the worldwide development and commercialization of this regimen.

(Prezista boosted with Cobicistat in an FDC is already sold under the brand name, Prezcobix in the US (#msg-110465571) and the brand name, Rezolsta in the EU.)