ViiV Healthcare, a subsidiary of GlaxoSmithKline (NYSE:GSK), has received marketing authorization from China's National Medical Products Administration (NMPA) for its cabotegravir treatment, Vocabria. This approval will allow the drug to be used in conjunction with Janssen's Rekambys (rilpivirine) to treat HIV-1 infection among patients who are virologically suppressed on a stable antiretroviral (ARV) regimen.
The NMPA approval follows the authorization for rilpivirine long-acting injection on Tuesday, October 18, 2023, and cabotegravir's approval in July 2023. The combination of these drugs significantly reduces treatment dosing days from 365 to either 12 or 6 per year after initiation. This marks a critical advancement in China, where an estimated 1.045 million people are living with HIV.
The approval decision was based on three clinical trials: ATLAS, FLAIR, and ATLAS-2M. These studies involved over 1,200 participants from 16 countries and demonstrated the safety and efficacy of cabotegravir and rilpivirine compared to standard oral regimens.
Vocabria tablets can now be used with rilpivirine tablets either as an oral option prior to injection or when patients miss scheduled injections. This development is expected to transform the treatment experience for some people living with HIV in China, particularly those facing challenges with daily HIV therapies.
Deborah Waterhouse, CEO of ViiV Healthcare, emphasized the company's dedication to providing innovative solutions for HIV treatment. She expressed anticipation about working closely with Chinese partners to make this long-acting regimen accessible.
Despite these advancements, GSK's shares remained steady at 1,482.80 pence each today.
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