TGA begins ‘first step’ in approval process for new COVID drug скачать в хорошем качестве

TGA begins ‘first step’ in approval process for new COVID drug

A new drug to treat COVID-19 has been expedited by the Therapeutic Goods Administration with SOTROVIMAB - developed by pharmaceutical company GlaxoSmithKline - shown to reduce hospitalisations among COVID patients by 85 per cent. GSK Medical Lead of COVID Therapeutics Krystal Evans said, “we were very encouraged by the announcement last week from the TGA that our COVID-19 monoclonal antibody has been granted this provisional designation.” “It’s the first time that a monoclonal antibody has gone down this pathway with the TGA and what it means is that it’s the first step in the process. “It’s not approved yet, but now the TGA will be able to use this pathway to fast track their review”. Ms Evans told Sky News monoclonal antibodies are “specifically designed” to target the virus which causes COVID-19. “If you imagine the picture of the coronavirus with the spike protein a monoclonal antibody comes along and binds specifically to the spike protein and essentially neutralises the virus,” she said. “It also flags and tags the virus for the attention of the immune system to potentially help clear the infection faster. “That’s why we feel monoclonal antibodies may play a role in the potential treatment of COVID-19, particularly if they can be used ... early in infection”.