Viiv Healthcare Ltd., late Thursday, won FDA approval for Rukobia (fostemsavir), a gp120-directed attachment inhibitor for the treatment of adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance or safety considerations. The drug was reviewed under FDA's fast track and breakthrough therapy status programs.
"Significant advances over the past few decades have dramatically improved HIV treatment and for many, HIV is considered a manageable life-long condition," the company said. "However, heavily treatment-experienced (HTE) adults – which account for approximately 6% of adults living with HIV who are on treatment – have little to no options left due to resistance, tolerability or safety considerations."
It wasn't immediately clear how much the medicine would cost or when it would be available to the estimated 8,000 to 10,000 multidrug-resistant HIV-1 patients living in the U.S. An analyst consensus forecast compiled by Cortellis suggests the drug might generate a modest $107 million in sales in 2021, with sales potentially climbing to $290 million by 2025.
The approval was supported by data from the phase III BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimized background therapy (OBT) in 371 HTE adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry. In the randomized cohort, 60% of people who received Rukobia in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically meaningful improvements to CD4-positive T-cell count through week 96.
The drug binds to gp120 on the HIV virus rather than binding to the host cell, thus blocking HIV at an earlier life-cycle stage and having broader activity against HIV strains vs. earlier fusion inhibitors.
London-based Viiv is majority owned by Glaxosmithkline plc, with Pfizer Inc. and Shionogi Ltd. as shareholders. It acquired Rukobia, formerly known as BMS-663068, from Bristol-Myers Squibb Co. when that company exited the development of HIV therapies.
Fostemsavir is currently under review by the EMA and additional submissions to regulatory authorities around the world are planned throughout 2020 and 2021, Viiv said.