Asa Butcher, Editor GB Times, writes China’s 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 said that its investigational new drug application (IND), the means by which a pharmaceutical company obtains permission to start human clinical trials, had been granted permission to initiate phase II clinical trials by the US federal agency 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.
When asked for details surrounding Frontier Biotech’s approval, the FDA told gbtimes.com that they cannot confirm or deny the existence of a pending product application or discuss the status of a pending application.
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.
Approval of ABT in China was a major milestone, said Dr Dong Xie, chairman of Frontier Biotech, who further noted that the FDA approval means they can continue developing a complete regimen with an all-injectable, long-acting new drug combination, while providing preferred solutions to HIV patients globally.
As of September 2017, the number of people estimated to be living with HIV in China was 747,000. There are also approximately 36.7 million people living with HIV in the world.