FDA Approves First COVID-19 Antiviral Treatment That May Increase Testing Volumes for Clinical Laboratories

First treatment for COVID-19 gains FDA approval, but it requires multiple clinical laboratory tests during administration

The antiviral drug Veklury (remdesivir) became the first treatment for COVID-19 to gain US Food and Drug Administration (FDA) approval. The FDA announced the approval of this medication Oct. 22, 2020. The approval for Veklury only permits the antiviral drug for COVID-19 to be used in a hospital or healthcare setting, and only for patients who are 12 years old and older and weighing at least 40 kilograms.

While other treatments, such as convalescent plasma, have previously gained FDA authorization under emergency use authorizations (EUAs), FDA approval of this antiviral drug for COVID-19 “requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s).” This is a far more rigorous process than is required to obtain an EUA, meaning that Veklury has been proven to be effective. The FDA made its approval determination based on three randomized, controlled clinical trials of the drug that is given through a vein by intravenous (IV) infusion.

“The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,” FDA Commissioner Stephen M. Hahn, MD, said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

While this important milestone is exciting, it does bear particular relevance for clinical laboratories. With the approval of Veklury to treat COVID-19, it is likely that the use of the medication will often be preferred by clinicians based on the evidence that supports it. Veklury, however, does require the monitoring of laboratory values before and during treatment. This could lead to increased test volumes for clinical laboratories where this form of treatment is used.

COVID-19 Vaccine Requires Monitoring With Multiple Clinical Lab Tests

Per the FDA approval, Veklury requires multiple clinical lab tests, that should be performed prior to and during therapy. According to the package insert, clinical laboratories and clinicians should collaborate to:

1. Determine eGFR in all patients before starting Veklury, and monitor while receiving Veklury as clinically appropriate.
2. Perform hepatic laboratory testing in all patients before starting Veklury and while receiving Veklury as clinically appropriate.
3. Determine prothrombin time (PT) in all patients before starting Veklury and monitor while receiving Veklury as clinically appropriate.

These tests are recommended to be monitored throughout the course of the COVID-19 treatment.

As Veklury is set to become more prominently used throughout the United States following its approval, clinical laboratory leaders should collaborate with providers to determine what testing protocols will be needed to ensure patients’ safety while taking Veklury. This will not only help patients to receive this potentially life-saving therapy in the safest way possible, but may also help to offset the decreases in laboratory testing volumes that have been experienced by many clinical laboratories.

While still an unknown, it is possible that the recent approval of Veklury may also increase the number of people seeking COVID-19 testing. With an FDA-approved treatment now available, the general public may be more likely to seek out COVID-19 testing in hopes of obtaining this treatment.