HIV Treatment Bulletin

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.

Reference:

ViiV Healthcare press statement. ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines. (01 June 2017).

https://www.viivhealthcare.com/media.aspx

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