Coformulated dolutegravir plus rilpivirine approved in US (Juluca)

24 November 2017. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 21 November 2017, the US FDA approved the first two-drug, single tablet, fixed dose combination (FDC). [1]

The FDC includes dolutegravir (50 mg) and rilpivirine (25 mg) and has an indication as switch therapy in HIV positive people who have been on stable ART for more than six months with no history of drug resistance. The pharmacokinetic importance of food for boosting rilpivirine means this FDC needs to be taken with food.

Approval is based on results from the phase 3 studies – SWORD 1 and SWORD 2.

This FDC is marketed by ViiV Healthcare with the brand name Juluca.

Please see prescribing information for more details. [2]

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Juluca was submitted to the EMA in June 2017, with a decision on European approval expected early in 2018. [3]

If approved, market authorisation show be available in the second half of 2018.

References:

1. ViiV Healthcare press statement. Dolutegravir and rilpivirine (Juluca) approved in US as first 2-drug regimen once-daily single pill – a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection (21 November 2017).
   https://www.viivhealthcare.com/media.aspx
2. ViiV Healthcare. Highlights of prescribing information (Juluca). November 2017.
   https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Juluca/pdf/JULUCA-PI-PIL.PDF (PDF)
3. ViiV Healthcare press statement. ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines. ()1 June 2017).
   https://www.viivhealthcare.com/media/press-releases/2017/june/viiv-healthcare-submits-regulatory-applications-for-the-first-hiv-maintenance-regimen-comprising-only-two-medicines.aspx