Chinese regulator approves complete HIV-1 injectable

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The National Medical Products Administration (NMPA) of China has approved ViiV Healthcare’s Vocabria (cabotegravir injection) in combination with Janssen’s Rekambys (rilpivirine long-acting injection) for the treatment of HIV-1 infection.

Cabotegravir injection and tablets were approved in China in July 2023.

Cabotegravir injection is indicated in adults who are virologically suppressed, on a stable antiretroviral (ARV) regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) classes.

Vocabria (cabotegravir) tablets are also approved for use in combination with rilpivirine tablets (trade name Edurant) as an optional oral lead-in before initiating injections or as oral therapy for those who will miss planned injection doses.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “The approval of cabotegravir injection and rilpivirine long-acting injection marks a step forward in helping to change the treatment experience for some people living with HIV in China who may have challenges with daily HIV therapies.”

The approval is based on data from three pivotal trials: the ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies, and the Phase IIIb ATLAS-2M study, which collectively included more than 1,200 participants from 16 countries.

ATLAS and FLAIR demonstrated the efficacy and safety of cabotegravir and rilpivirine compared to standard-of-care oral regimens, while ATLAS-2M showed that dosing once every two months had comparable efficacy to once monthly.

In ATLAS, 92.5% of participants receiving long-acting therapy and 95.5% of those receiving oral therapy remained virally suppressed at week 48. In FLAIR, 93.6% of participants receiving long-acting therapy and 93.3% of participants receiving oral therapy remained virally suppressed at week 48.

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