Dolutegravir/rilpivirine submitted to EMA and FDA as oral two-drug maintenance combination
Simon Collins, HIV i-Base
On 1 June 2017, ViiV Healthcare submitted a new drug application to the US FDA for the two-drug oral combination of dolutegravir and rilpivirine.
This is an unusual in several respects: for combining only two drugs (rather than three or more) with and indication of maintenance treatment (ie as a switch rather than first-line combination)
The submissions are based on the SWORD 1 and 2 studies that were presented at the 2017 Conference on Retroviruses and Opportunistic Infections in February.
The US submission uses a priority review voucher to get an expedited review, usually within six months. Vouchers are commercially traded between companies with this one costing US$130 million.
As separate drugs, dolutegravir is marketed as Tivicay by ViiV Healthcare and rilpivirine is marketed as Edurant by Janssen Sciences.
ViiV Healthcare press statement. ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines. (01 June 2017).