The EUA authority is intended to allow the Food and Drug Administration (FDA) to help enhance public protection against serious, life-threatening diseases or conditions. In these cases, the FDA can allow either unapproved medical products, or approved medical products unapproved for a certain use, to be used in emergency situations where there are no, or limited, approved alternatives.
Both remdesivir (Veklury®) and convalescent plasma have received EUAs for specific purposes.
Remdesivir is an antiviral agent that inhibits replication (growth) of viral cells. The EUA for remdesivir is indicated to be used in hospitalized patients with either suspected or confirmed COVID-19 infection. At this point, the medication is limited to hospitalized patients as there is not enough evidence to support use in non-severe patients. With a price tag of over $3,000 for a 5-day course, the medication has been shown to shorten recovery in hospitalized patients by 2-3 days.
Convalescent plasma has also received an EUA from the FDA for use in hospitalized patients, but there is limited data regarding the impact on patient outcomes at this time. The plasma is derived from people who have recovered from the illness (e.g. COVID-19) as it contains antibodies that help fight off the infection when administered to sick patients. While plasma can be given as either part of a clinical trial protocol or outside of a trial, some experts suggest for now it should be part of a clinical trial. In cases where the treatment is given outside of a clinical trial, the FDA has put together an EUA Fact Sheet regarding convalescent plasma covering key points about the treatment along with potential side effects.
More recently, both Regeneron Pharmaceuticals, Inc., and Eli Lilly have asked federal regulators to consider EUAs for their experimental antibody treatments. Regeneron’s request is based on data from a trial showing a reduction in virus levels in COVID patients treated outside of the hospital. Eli Lilly has stated a trial has shown that for patients with mild-to-moderate COVID-19 infection, their antibody-based treatment reduced the hospitalization rate. As of the time of this article, a decision has not been made regarding whether or not either product will receive the EUA.
The development of these products, along with the endorsement by the FDA through EUA-authorizations gives us hope that we are on the path to finding a treatment for COVID-19 infections. As we gain more experience with these treatments, research is also progressing with exploring other options and a vaccine to bring an end to the pandemic. Thanks for stopping by and see you next month.