ViiV secures European marketing authorisation for fostemsavir

ViiV Healthcare has secured European Marketing Authorisation of Rukobia (fostemsavir), a first-in-class attachment inhibitor in combination with other antiretrovirals for the treatment of adults with multidrug-resistant HIV.

Specifically, the treatment is approved for use in combination with other antiretroviral (ARV) therapies for the treatment of adults with multidrug-resistant HIV-1 infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

“In clinical trials, fostemsavir, in combination with other antiretroviral therapies, demonstrated sustained rates of virologic suppression and clinically meaningful CD4+ T-cell recovery offering us a long-awaited new option for this specific HIV community,” said Prof Carlo Federico Perno, Director, Microbiology and Diagnostic Immunology, Paediatric Hospital Bambino Gesu’, Rome.

The Marketing Authorisation Application (MAA) for fostemsavir is supported by data from the pivotal phase III BRIGHTE study, which evaluated the safety and efficacy of fostemsavir in combination with an optimised background therapy (OBT) in heavily treatment experienced (HTE) adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry.

In the randomised cohort, 60% of individuals who received fostemsavir in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically significant improvements to CD4+ T-cell count through Week 96.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “There have been great strides in the HIV treatment landscape over the last few decades, however, there still remains a small subset of people living with multi-drug resistant HIV who are at risk of having their disease progress.

“The Marketing Authorisation for fostemsavir marks a significant milestone, as it addresses a critical unmet need in HIV care for those with little or no treatment options left. At ViiV Healthcare, through our pioneering research and development, we aim to meet the diverse needs of the HIV community.”

Fostemsavir, under the brand name Rukobia, was licensed by the US Food and Drug Administration on 2 July 2020, and further regulatory applications have been submitted worldwide.

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