HTB

Darunavir-based single pill FDC approved in EU (Symtuza)

Simon Collins, HIV i-Base

On 27 September 2017, the first protease inhibitor-based fixed dose combination (FDC) was approved in Europe by the European Medicines Agency (EMA). [1]

The once-daily FDC combines darunavir 800 mg, cobicistat 150 mg and emtricitabine/tenofovir alafenamide 200 mg/10 mg fixed-dose combination (D/C/F/TAF).

The indication is for HIV positive adults and adolescents aged 12 years and older.

The combination needs to be taken once-daily with food. Approval is based on phase 3 studies showing bioequivalence to the indiviaul companents being taken separately.

This FDC is marketed by Janssen-Cilag with the brand name Symtuza.

For full details see the SPC and patient information on the EMA website. [2]

References:

  1. Janssen press statement. European Commission approves Symtuza for the treatment of HIV-1 in adults and adolescents in Europe. (27 September 2017).
    http://www.investor.jnj.com/releases.cfm
  2. European Summary of Product Charateristics (SPC) for Symtuza. (September 2017).
    http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004391/human_med_002165.jsp&mid=WC0b01ac058001d124

Links to other websites are current at date of posting but not maintained.