FDA OKs ViiV Healthcare's fostemsavir for HIV-1

• ViiV Healthcare, majority owned by GSK, with Pfizer and Shionogi as shareholders, announced the FDA nod for Rukobia (fostemsavir), a human immunodeficiency virus type 1 gp120-directed attachment inhibitor, in combination with other antiretrovirals, for HIV-1 infection
• The approval of 600 mg extended-release tablets, is for heavily treated adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
• Fostemsavir is currently under review by the European Medicines Agency and additional submissions to regulatory authorities in other countries are planned throughout 2020 and 2021.

Comments

[mechan1sm]

This is the first approval of a drug that blocks the Envelope protein attaching to CD4 on target cells. This compound was acquired when ViiV Healthcare purchased BMS’s antivirals unit in Connecticut.

So many firsts in drug development have happened in the HIV field.

[DoctoRx]

Good work by GSK/ViiV. This gives them a significant lead over GILD in this market niche:
clinicaltrials.gov/...