Edurant (dolutegravir) + Tivicay (rilpivirine) filed with EU and FDA for HIV- Janssen/ViiV Healthcare

Janssen Sciences announced that ViiV Healthcare has made regulatory submissions to both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for a single-tablet, two-drug regimen of Edurant + Tivicay (dolutegravir), from ViiV Healthcare and (rilpivirine) from Janssen. If approved, this will be the first two-drug regimen for the maintenance treatment of HIV-1 infection and will offer those living with HIV who are virally suppressed the option to switch to a regimen which does not include a nucleotide reverse transcriptase inhibitor (NRTI).

The submissions are based on the Phase III SWORD studies which included more than one thousand patients who previously achieved viral suppression on a three or four drug antiretroviral regimen. The data were presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in February.

A Priority Review voucher was submitted to the FDA along with the dolutegravir and rilpivirine two-drug regimen New Drug Application (NDA). Under the Prescription Drug User Fee Act, the anticipated target action date is six months after receipt of the application by the FDA.