FDA approves ViiV Healthcare’s HIV treatment

By Jenni Spinner contact

- Last updated on GMT

(ClaudioVentrella/iStock via Getty Images Plus)
(ClaudioVentrella/iStock via Getty Images Plus)

Related tags: Fda, Hiv, ViiV Healthcare, Clinical trials

The agency has given the thumbs up for Rukobia, a treatment designed for HIV patients facing poor results with current antiretroviral therapies.

ViiV Healthcare, an HIV specialist company majority-owned by GSK, has announced the US Food and Drug Administration (FDA) has approved Rubobia (forstemsavir) 600-mg extended release tablets for treatment. The drug is a novel attachment inhibitor for treating HIV-1 infection in combination with other antiretroviral (ARV) therapies in adults dealing with multidrug-resistant infection.

Phase III trial

In a recent Phase III study, a majority of heavily treatment-experienced (HTE) adults, randomized to receive Rukobia with an optimized background therapy, reportedly achieved and maintained viral suppression through 96 weeks. While HIV is considered a manageable condition for most patients, the approximately 6% of HIV patients that are HTE are at risk of developing AIDS and require additional therapies.

ViiV Healthcare CEO Deborah Waterhouse said Rukobia is designed to fulfill an unmet need for these highly at-risk HIV patients.

“There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS. The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind,​” she said.

The FDA’s approval of the drug reportedly was supported by data from the Phase III BRIGHTE study, intended to evaluate the safety and efficacy of Rukobia in combination with optimized background therapy (OBT) in HTE adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry. In the randomized cohort, 60% (n=163/272) of individuals who received Rukobia in combination with an OBT managed to achieve an undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count through Week 96.

According to study managers, the proportion of participants who discontinued treatment with Rukobia due to an adverse event was 7% at Week 96 (randomized: 5% and nonrandomized: 12%). The most common adverse reactions (all grades) observed in randomized and nonrandomized participants were nausea, fatigue and diarrhea.

Additionally, the most common adverse events leading to discontinuation were related to infections (3%). Serious drug reactions occurred in 3% of people taking Rukobia and included three cases of severe immune reconstitution inflammatory syndrome.

'Exciting advances'

Jacob Lalezari, CEO and director of Quest Clinical Research, said, “These are exciting advances for the HTE population and an advancement the HIV community has long been waiting for.  As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV​.”

The drug was reviewed and approved under the FDA’s Fast Track and Breakthrough Therapy Designations, designed to facilitate and expedite development and review of new drugs to address unmet medical needs in treating a serious or life-threatening condition. 

Fostemsavir reportedly is under review by the European Medicines Agency (EMA). Additional submissions to regulatory authorities around the world are planned throughout 2020 and 2021.

Earlier this year, Health Canada approved Cabenuva​, ViiV Healthcare's once-monthly HIV regimen.

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