Gilead’s Veklury receives FDA approval for non-hospitalised high-risk patients to treat COVID-19
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has granted a rapid approval of a supplemental drug application for Veklury (remdesivir) for the treatment of non-hospitalised adult patients who are deemed to be at high risk of severe COVID-19.
With the FDA’s approval, Veklury is further expanded, having been used as the antiviral standard of care for patients hospitalised with the virus. The treatment is now allowed to be administered via daily intravenous infusions over the course of three consecutive days in qualified outpatient environments.
In addition, the FDA’s expanded indication of the emergency use authorisation (EUA) for Veklury is set to include non-hospitalised paediatric patients who are 12 years of age and under who are at high risk of disease progression.
The approval follows a rapid increase in COVID-19 cases coupled with the reduced sensitivity to various anti-SARS-CoV-2 monoclonal antibodies due to the recent and highly-transmissible Omicron variant.
Veklury works by targeting the viral RNA polymerase, retaining activity against severe SARS-CoV-2 variants, with in vitro laboratory trials demonstrating Veklury’s effectiveness in retaining activity against the Omicron variant.
So far, there have been no major genetic changes recorded or identified in any existing variants of concern that might significantly change the viral RNA polymerase targeted by Veklury.
Read more: https://www.pmlive.com/pharma_news/gileads_veklury_receives_fda_approval_for_non-hospitalised_high-risk_patients_to_treat_covid-19_1386701
With the FDA’s approval, Veklury is further expanded, having been used as the antiviral standard of care for patients hospitalised with the virus. The treatment is now allowed to be administered via daily intravenous infusions over the course of three consecutive days in qualified outpatient environments.
In addition, the FDA’s expanded indication of the emergency use authorisation (EUA) for Veklury is set to include non-hospitalised paediatric patients who are 12 years of age and under who are at high risk of disease progression.
The approval follows a rapid increase in COVID-19 cases coupled with the reduced sensitivity to various anti-SARS-CoV-2 monoclonal antibodies due to the recent and highly-transmissible Omicron variant.
Veklury works by targeting the viral RNA polymerase, retaining activity against severe SARS-CoV-2 variants, with in vitro laboratory trials demonstrating Veklury’s effectiveness in retaining activity against the Omicron variant.
So far, there have been no major genetic changes recorded or identified in any existing variants of concern that might significantly change the viral RNA polymerase targeted by Veklury.
Read more: https://www.pmlive.com/pharma_news/gileads_veklury_receives_fda_approval_for_non-hospitalised_high-risk_patients_to_treat_covid-19_1386701
