#ViiV Healthcare

The Food and Drug Administration declined approval of ViiV Healthcare’s injectable HIV regimen Cabenuva.

ViiV applies for FDA approval of HIV drug fostemsavir

The FDA recently held up the U.S. approval based on concerns over the monthly injectable regimen’s manufacturing.

Whether given every four or eight weeks, long-acting injections of cabotegravir and rilpivirine suppressed HIV equally well.

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The agency expressed concerns about the monthly injectable regimen’s chemistry and manufacturing controls.

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Long-acting injectables may be given once every other month, according to new findings.

An analysis of 15,000 insured people with HIV also confirmed past findings that single-tablet regimens are associated with higher adherence.

The attachment inhibitor plus an optimized antiretroviral background regimen suppressed HIV in the majority of study participants.

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Recently, ViiV Healthcare applied for approval of the first long-acting injectable HIV regimen.