GlaxoSmithKline's ViiV Healthcare receives FDA approval for Apretude
By Iain Gilbert
Date: Tuesday 21 Dec 2021
(Sharecast News) - Pharmaceutical giant GlaxoSmithKline said on Tuesday that ViiV Healthcare, its majority-owned subsidiary, had received approval from the Food and Drug Administration for Apretude, a long-acting injectable pre-exposure prophylaxis option that reduces the risk of sexually acquired HIV-1.
GlaxoSmithKline, which owns ViiV with Pfizer and Shionogi, stated the long-acting injectable had been approved for use in adults and adolescents weighing at least 35.0kg and were at risk of sexually acquiring HIV and who had turned in a negative HIV-1 test prior to initiation.
The FTSE 100-listed firm highlighted that the medicine had been studied in men who had sex with men, as well as women and transgender women who had sex with men, who it said were at an increased risk of sexually acquiring HIV.
Viiv's studies also showed that when given as few as six times per year, Apretude had demonstrated "superior efficacy" to a daily oral PrEP option in reducing the risk of HIV acquisition.
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