Ni dawa inayosemekana inatibu covidi kwa asilimia miamoja na pia kuwaepusha wagonjwa katika chumba cha kusubiria kifo. Nenda kaguguli uone huko duniani kumebadilika.
The European Medicines Agency approved Sotrovimab for select COVID-19 patients on May 21, 2021. The United States Food and Drug Administration provided emergency use approval (EUA) to Sotrovimab, which it classifies as an ‘investigational monoclonal antibody therapy’, on May 26.
The UAE Ministry of Health and Prevention (MoHAP) went on to approve the therapy days later, on May 29.
The therapy received an emergency-use approval or EUA, rather than a Food and Drug Administration approval in the US. This means that the US body that approves medications followed an atypical development and approval process due to the public health emergency created by the COVID-19 pandemic. Under an EUA, in an emergency, the FDA makes a product available to the public, based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.
When was Sotrovimab approved?
The European Medicines Agency approved Sotrovimab for select COVID-19 patients on May 21, 2021. The United States Food and Drug Administration provided emergency use approval (EUA) to Sotrovimab, which it classifies as an ‘investigational monoclonal antibody therapy’, on May 26.
The UAE Ministry of Health and Prevention (MoHAP) went on to approve the therapy days later, on May 29.
Why is Sotrovimab called an investigational therapy?
The therapy received an emergency-use approval or EUA, rather than a Food and Drug Administration approval in the US. This means that the US body that approves medications followed an atypical development and approval process due to the public health emergency created by the COVID-19 pandemic. Under an EUA, in an emergency, the FDA makes a product available to the public, based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.