HTB

Fostemsavir submitted to EMA for treating multidrug resistant HIV

Simon Collins, HIV i-Base

On 10 January 2020, ViiV Healthcare submitted a regulatory application for fostemsavir to the European Medicines Agency (EMA). [1]

The application seeks approval of fostemsavir, used in combination with other antiretrovirals, for the treatment of adults with multidrug resistant HIV who are otherwise unable to construct a suppressive antiviral regimen due to resistance, intolerance or safety considerations.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted an accelerated assessment for fostemsavir. This reduces the timeframe for review based on meeting a currently unmet medical need.

Submission is based on the 96-week results from the phase 3 BRIGHTE study presented at the 10th IAS Conference on HIV Science (IAS 2019) in Mexico City. [2]

A similar application to the US FDA was submitted in December 2019, also with accelerated approval status. [3]

References

  1. ViiV Healthcare press statement. ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available. (10 January 2020).
    https://viivhealthcare.com/en-gb/media/press-releases/2020/january/viiv-healthcare-submits-regulatory-application-to-the-european-m
  2. Fostemsavir: 96-week follow-up in people with multi-drug resistance. HTB, 24 July 2019.
    https://i-base.info/htb/36390
  3. Fostemsavir submitted to US FDA for multidrug resistant HIV. HTB December 2019.
    http://i-base.info/htb/36951

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