Fostemsavir is an innovative new approach to HIV treatment that could help treatment experienced people everywhere.
On January 10th 2020 ViiV Healthcare announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection.
ViiV’s application seeks approval of fostemsavir, used in combination with other antiretrovirals, for the treatment of adults with multi-drug resistance who have far fewer treatment options available due to resistance, intolerance or drug-drug interactions.
Fostemsavir is a the first in a new class of HIV treatments known as ‘attachment inhibitors’ that work by binding directly to the glycoprotein 120 (gp120) subunit on the surface of the virus. By binding to this location on the virus, fostemsavir blocks HIV from attaching to host immune system CD4+ T-cells and other immune cells, thereby preventing HIV from infecting those cells and multiplying.
Because of this unique mechanism of action, there is no demonstrated resistance to other classes of antiretrovirals, which may help patients who have become resistant to most other medicines. Fostemsavir is yet to receive regulatory authorisation for prescription to patients in any country.
The efficacy of fostemsavir in heavily treatment-experienced adults with HIV-1 infection is based on 96-week data from the phase III, partially-randomised, international, double-blind, placebo-controlled BRIGHTE study.
At Week 96, 60% of patients receiving fostemsavir plus an optimised background therapy in the randomised cohort (n=163/272) achieved virologic suppression (a viral load below 40 copies / mL) as well as a mean change from baseline of +205 CD4+ T-cells / mL.
Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare, said: “The efficacy and safety findings from fostemsavir’s clinical development program demonstrate its unique potential for people living with multidrug-resistant HIV who are in need of new treatment options. Developing this medicine exemplifies ViiV’s mission and commitment to ensuring that no person living with HIV is left behind. We look forward to working with the EMA to make fostemsavir available to the people in Europe who need it.”
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted an accelerated assessment for the fostemsavir authorisation. Accelerated assessment reduces the timeframe for review and is awarded if the CHMP determines the product is of major interest for public health and therapeutic innovation.
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