Glaxo’s HIV injection approved by the US
AN INJECTABLE drug made by Glaxosmithkline that prevents HIV has been approved by US regulators.
The Food and Drug Administration (FDA) became the first regulator to approve cabotegravir, which is marketed under the name Apretude.
The drug can prevent HIV infection if patients receive a dose every two months, in contrast to current HIV prevention pills that need to be taken every day.
It has been developed by Viiv Healthcare, a HIV specialist company in which GSK owns a controlling stake.
US pharma giant Pfizer and Japanese group Shionogi are also shareholders. The FDA’s approval followed two clinical trials that showed cabotegravir was more effective at preventing HIV infection than daily oral tablets.
The trials involved people at risk of HIV from sex.
Shipments of cabotegravir to distributors in the US are expected to begin early next year, costing around £2,793 per dose for American patients.
Viiv has also requested approval for the drug from other regulators across the world. ‘[This] approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill’, said Debra Birnkrant, the director of the antivirals division at the FDA drug evaluation centre.
Viiv’s chief executive Deborah Waterhouse added: ‘Today’s approval is the latest example of Viiv Healthcare’s commitment to developing long-acting medicines that offer consumers a different choice.’
Shares in GSK inched up 1pc, or 16p to 1607.8p. The regulatory approval is another boost for its HIV drugs push after the National Institute for Health and Care Excellence (Nice), which authorises the use of drugs in England and Wales, last month approved a Viiv treatment for people who have HIV.
The drug, cabenuva, allows HIV-positive patients to take an injection every two months rather than take daily tablets.
Last week, Nice also recommended for the first time that those at highest risk of catching HIV should be offered prevention medication as the Government seeks to eliminate HIV transmission by 2030.