GSK's Dolutegravir Sodium Dispersible Tablets Approved in China for Pediatric HIV-1 Treatment

On June 2, the official website of the National Medical Products Administration (NMPA) showed that GSK's Dolutegravir Sodium Dispersible Tablets had been approved for marketing, with speculation that this indication is for the treatment of pediatric HIV-1 infection.

Dolutegravir (brand name: Tivicay), developed by ViiV Healthcare, a subsidiary of GSK, is an HIV integrase inhibitor that blocks HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells.

Dolutegravir Sodium Tablets were first launched in the United States in August 2013, followed by the EU in January 2014, and entered the Chinese market in December 2015 for the treatment of adult and HIV patients aged 12 years and above. Dolutegravir Sodium Dispersible Tablets were launched in the United States in November 2020 and in the EU in January 2021 for the treatment of pediatric HIV patients. In terms of market performance, the sales revenue of Dolutegravir in 2022 was 1.381 billion pounds.

Notably, the core patent for dolutegravir is set to expire in 2028. Dolutegravir is also a component of four GSK HIV products: Tivicay, Triumeq (dolutegravir/abacavir/lamivudine), Juluca (dolutegravir/rilpivirine), and Dovato (dolutegravir/lamivudine).

The recently approved drug is Dolutegravir Sodium Dispersible Tablets, which disintegrate uniformly and rapidly in water, making them suitable for pediatric HIV patients. Compared with conventional tablets, dispersible tablets offer advantages such as convenient administration, rapid absorption, high bioavailability, and minimal adverse reactions.

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