GSK granted US FDA approval for Covid-19 antibody drug
GlaxoSmithKline (GSK) and Vir Biotechnology have been granted emergency authorisation in the US for their Covid-19 antibody drug used to reduce the impact of the virus on patients with mild-to-moderate symptoms.
The US Food and Drug Administration (FDA) gave an emergency use authorisation to the antibody drug for treating mild-to-moderate Covid-19 in people aged 12 years and older.
It follows similar authorisation from the EU last week.
The antibody drug, Sotrovimab, is not authorised for patients who are hospitalized due to Covid-19 or require hospitalisation.
Sotrovimab is classed as a group of monoclonal antibodies, which mimic natural antibodies that the body generates to fight off infection.
The antibody treatment will be available for Covid-19 patients in the coming weeks, GSK and Vir said, adding that they plan to submit a marketing application to the FDA in the second half of 2021.
Dr Hal Barron, chief scientific officer and President R&D at GSK, said: “The fast pace of COVID-19 vaccinations in the US is encouraging, yet, despite these aggressive efforts, there is still a need to help prevent infected patients from developing complications.
“In just over a year since starting our collaboration and in less than 10 months since beginning clinical trials, we are delighted that, as of today, the benefits of this unique monoclonal antibody will now be available to patients in need.”