ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, announced the authorisation of Vocabria (cabotegravir injection and tablets) in combination with Janssen Pharmaceutical Companies of Johnson & Johnson’s Rekambys (rilpivirine injection) and Edurant (rilpivirine tablets), in the European Union, for the treatment of HIV-1 infection in adults who are virologically suppressed.
Cabotegravir injection is indicated, in combination with rilpivirine injection, for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. This authorisation represents the first time people living with HIV in Europe may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets, following the oral initiation phase.