GSK's ViiV gets EU approval for long-acting HIV injectable

European Union flags waving in front of the EU Parliament building in Brussels
The European approval for ViiV Healthcare's HIV treatment Vocabria comes nine months after Health Canada became the first regulator to clear the drug. (artJazz/iStock/Getty Images Plus/Getty Images)(Photo by artJazz/iStock/Getty Images Plus/Getty Images)

ViiV Healthcare has won approval for its long-acting injectable HIV treatment Vocabria in Europe. The authorization clears ViiV to sell a drug that could reduce the number of doses patients need to take a year from 365 to six.

Combinations of oral antiretrovirals, such as ViiV’s own Combivir and Trizivir, form the backbones of treatment regimens that suppress HIV. However, compliance to daily regimens is imperfect, raising the risk levels of the virus will rise. ViiV also identified the fact daily doses constantly remind people of their infection and create fear of the inadvertent disclosure of HIV status as downsides to current regimens.

Vocabria is designed to eliminate those problems. The EU has authorized the injectable for use every month or every two months. Patients who currently take oral medication every day may be able to move to bimonthly injections.

ViiV, a venture involving GlaxoSmithKline, Pfizer and Shionogi, secured the approval on the strength of data from three phase 3 clinical trials. The studies showed intramuscular injections of Vocabria and Johnson & Johnson’s Rekambys are as effective at maintaining viral suppression as daily doses of oral antiretrovirals.

Armed with the data, ViiV will now make the case for switching patients to Vocabria and Rekambys. ViiV has data to suggest many patients will support the switch. A ViiV study of more than 2,300 HIV patients found 55% of people would prefer not to take daily medications. Almost 40% of patients reported anxiety around the potential for their daily treatments to reveal their HIV status to others. 

The European approval comes nine months after Health Canada became the first regulator to clear the drug, sold in that market as Cabenuva, for use. ViiV had expected to pick up a FDA approval this year as well but was hit with a complete response letter over manufacturing issues 12 months ago. ViiV refiled for approval in the U.S. over the summer, setting it up for a 2021 decision by the FDA.