GSK HIV injection regimen gets approval in China

GSK announced on Thursday that its majority-owned HIV specialist subsidiary ViiV has received approval from the National Medical Products Administration (NMPA) of China for an injection regimen.

The FTSE 100 pharmaceuticals giant said the approval was for ‘Vocabria’, or cabotegravir injection, used in combination with Janssen Pharmaceutical’s ‘Rekambys’, or rilpivirine long-acting injection, for the treatment of HIV-1 infection.

It said the approval followed the earlier authorisation of cabotegravir injection and tablets in China in July.

Cabotegravir injection is designated for use alongside rilpivirine long-acting injection in adults with virologically-suppressed HIV-1 infection, maintaining a stable antiretroviral (ARV) regimen without evidence of viral resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) classes.

Vocabria tablets are also approved, offering an oral option before initiating injections or as an alternative for individuals missing planned injection doses when used with rilpivirine tablets, sold under the trade name ‘Edurant’.

As of October 2020, China had an estimated 1.045 million people living with HIV, and while advancements in treatment had allowed for improved quality of life, GSK said some individuals could face challenges with daily oral HIV medication.

The approval would thus provide an alternative treatment option, potentially reducing concerns related to medication adherence and HIV disclosure.

“At ViiV Healthcare, we are proud to be able to offer innovative solutions that meet the evolving needs of people living with HIV,” said ViiV chief executive officer Deborah Waterhouse.

“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.

“We look forward to working closely with our partners in China to make this treatment available to those who could benefit from a long-acting regimen, part of our commitment to ensuring no person living with HIV is left behind.”

Reporting by Josh White for Sharecast.com.