Shares in pharmaceutical company GlaxoSmithKline (GSK) ticked up 0.6% to £16.01 after announcing that its injectable HIV drug Apretude has been approved by the US medicines regulator.
The drug was developed by global specialist HIV company ViiV Healthcare, jointly owned by GlaxoSmithKline, US pharma company Pfizer and Japanese pharma company Shionogi Limited. ViiV generated annual sales of £4.88 billion in 2020.
Approval by the US FDA (Food and Drug Administration) means Apretude becomes the first and only long-acting injectable drug available to reduce the risk of sexually acquired HIV-1.
ViiV chief executive Deborah Waterhouse commented: ‘People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, may want options beyond daily oral pills.’
COMPREHENSIVE TRIALS
The approval was based on results from two trials which recruited over 7,000 participants across 13 countries and tested safety and efficacy of the drug in HIV-negative men who have sex with men, transgender women, and cisgender women, who were at increased risk of sexually acquiring HIV.
Trials were stopped early by an independent data safety monitoring board after the drug was shown to be superior to daily oral tablets in preventing acquiring the disease.
In a US trial which included Black/African American and Latinx communities of men and transgender women who have sex with men, participants receiving the drug had a 69% lower incidence of HIV compared with participants taking oral tablets.
In a trial involving cisgender women (people who identify as the same gender they were given at birth) from sub-Saharan Africa participants receiving the drug had a 90% lower incidence of HIV compared with those taking oral tablets.
There are an estimated 38 million people living with HIV globally and 1.7 million new cases every year.
