GSK plc (NYSE: GSK) has announced that ViiV Healthcare, an HIV specialist majority owned by GSK with Pfizer and Shionogi as shareholders, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the approval of Vocabria (cabotegravir long-acting injections) in combination with Rekambys for the treatment of HIV-1 infection in adolescents aged 12 years and older, weighing at least 35 kg, and who are virologically suppressed.
Vocabria and Rekambys: A Long-Acting HIV Regimen
The combination of Vocabria and Rekambys marks the world’s first complete, long-acting HIV regimen, administered intramuscularly on a monthly or bi-monthly basis. This innovative treatment approach offers a significant advancement in HIV management, providing a more convenient option for patients who are virologically suppressed and in need of a stable antiretroviral regimen.
US Approval and European Consideration
The combo therapy was approved in the US in January 2021 for the treatment of 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 non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class agents. The positive opinion from the CHMP paves the way for potential approval in the European market, further expanding access to this groundbreaking treatment for HIV-1 patients.-Fineline Info & Tech
