GSK’s ViiV Healthcare Secures NMPA Approval for Vocabria in HIV-1 Treatment

UK pharmaceutical giant GlaxoSmithKline (GSK, NYSE: GSK) has announced that its HIV joint venture, ViiV Healthcare, has received approval from China’s National Medical Products Administration (NMPA) for Vocabria (cabotegravir injection). The drug is approved for use in combination with Johnson & Johnson/Janssen Pharmaceutical’s (J&J, NYSE: JNJ) Rekambys (rilpivirine long-acting injection) for the treatment of HIV-1 infection. This marks a significant step forward in HIV treatment options, offering a long-term injection plan that can be administered as infrequently as once every two months.

Vocabria Tablet Approval and Usage
In addition to the injection, Vocabria (cabotegravir) tablets have been approved for use in combination with rilpivirine tablets (trade name Edurant). This provides an optional oral lead-in before initiating injections or serves as an oral therapy alternative for patients who may miss planned injection doses. This dual approval offers flexibility and convenience in treatment plans for patients living with HIV-1.

Cabotegravir and Rilpivirine: Mechanisms and Approvals
Cabotegravir, an integrase strand transfer inhibitor (INSTI) developed by ViiV, is designed for the treatment of HIV-1 in virologically suppressed adults. It has already been approved in the US, the EU, and other countries as a long-acting formulation for use in combination with a rilpivirine long-acting formulation. Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), works by inhibiting the enzyme reverse transcriptase, thereby preventing the virus from multiplying. It is approved as Edurant, an oral formulation, for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients aged 12 years and older with a viral load ≤100,000 HIV RNA copies/mL. The long-acting injection developed by Janssen Sciences Ireland Unlimited Company was approved for marketing in China in October, further expanding treatment options for HIV patients.-Fineline Info & Tech

Fineline Info & Tech