The National Medical Products Administration (NMPA) has granted marketing approval for GlaxoSmithKline’s (GSK, NYSE: GSK) cabotegravir, a significant development in HIV treatment options. Both the injection and tablet dosage forms of the drug have been approved for use in China.
Cabotegravir: An Innovative INSTI for HIV Treatment
Cabotegravir is an integrase strand transfer inhibitor (INSTI) developed by ViiV Healthcare. It works by inhibiting HIV integrase, binding to the active site of integrase, and blocking the chain transfer of retroviral DNA integration, a critical step in the HIV replication cycle. This once-every-two-months administration option offers a significant advantage over daily oral regimens, such as Gilead Sciences’ (NASDAQ: GILD) Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) or Eviplera (emtricitabine, tenofovir), potentially leading to improved patient adherence.
Global Approvals and Applications of Cabotegravir
Cabotegravir was first approved in the US in January 2021 to treat HIV-1 infection in combination with Johnson & Johnson’s rilpivirine. The drug expanded its reach to Brazil in June this year, where it is used as pre-exposure prophylaxis for HIV patients weighing at least 35 kg. The NMPA’s approval further broadens the drug’s global footprint, offering a new treatment option for patients in China.-Fineline Info & Tech
