Chinese first domestically-made anti-HIV drug has been given approval by the US Food and Drug Administration (FDA) to begin the next phase of clinical trials in America, according to a press release published by the drug’s developer this week.
Chinese research firm Frontier Biotech obtained permission to start human clinical trials. FDA granted permission to initiate phase II clinical trials on August 14.
Phase II trials assess the drug’s effectiveness on a larger group (100-300) of volunteers and patients, as well as testing its safety. When the development process for a new drug fails, it is often during this phase.
In July, the China Food and Drug Administration gave its own marketing authorisation, meaning that the new anti-HIV drug should be available for purchase on the Chinese mainland soon. It was also a rare case of an HIV treatment not being first approved in either Europe or the United States.
The anti-HIV two-drug combo (albuvirtide for injection, ABT and 3BNC117) aims to ease China’s reliance upon imported antiviral drugs and move people away from orally taking several tablets a day to just one injection a week.