Understanding the Benefits and Limitations of Remdesivir: A Closer Look at the First FDA-Approved Drug for Covid-19

Oct 27

A Closer Look at the First FDA-Approved Drug for Covid-19, Remdesivir

Remdesivir, sold under the brand name Veklury, is the first antiviral drug to be approved for treating Covid-19. Before its approval on October 22, 2020, remdesivir has been used under emergency use authorization since May, after a study conducted by the National Institutes of Health (NIH) showed it reduced hospital stays by five days. Remdesivir was one of the drugs used to treat U.S. President Donald Trump when he contracted Covid-19. The FDA’s official approval arrived just hours before Trump’s final debate with Joe Biden ahead of the presidential election in November.

In the U.S., remdesivir is approved for use in adults and children 12 years of age and older and weighing at least 40 kilograms (~88 pounds) for the treatment of Covid-19 requiring hospitalization. Remdesivir has regulatory approvals or temporary authorizations in about 50 additional countries. This antiviral drug is a nucleotide analog and an RNA polymerase inhibitor that is administered as IV (intravenous) infusion therapy. It should only be given in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. On October 22, the FDA also issued a new emergency use authorization for remdesivir to treat hospitalized pediatric patients under the age of 12 who weigh enough to receive an IV treatment, given that there aren’t any therapies approved to treat these patient populations.

The drugmaker Gilead Sciences Inc. submitted a study published in the New England Journal of Medicine (NEJM), which was the basis of FDA’s consideration for approval. A total of 1062 patients were evaluated in this clinical study with 541 receiving remdesivir and 521 receiving an inactive control product or placebo. Placebos are used to compare and measure the actual effectiveness of the active drug. In this study, remdesivir shortened the course of illness or recovery time by an average of 5 days. Those who received remdesivir had a median recovery time of 10 days compared to 15 days among those who received the inactive placebo. It is however important to note that the drug did not improve the overall survival outcome, even though the improvement in recovery time was an important milestone for Covid-19 clinical management. Remdesivir is now the standard of care for patients hospitalized with severe Covid-19 despite the lack of survival benefit.

Earlier in October, a World Health Organization (WHO)-sponsored global study found contradictory data to the study published in the NEJM; in the WHO-sponsored study, remdesivir did not improve the survival rates or the rate of recovery. That WHO study, however, has not been reviewed by outside experts. Gilead has questioned the potential for bias in the WHO study, which was not “blinded,” meaning that patients and their doctors were aware of who received the active drug versus the placebo control.

The FDA also reviewed two other studies. One demonstrated a slight benefit of the drug--although a not dramatic improvement, while the other study showed no difference.

Additionally, in the NEJM study, outcomes varied based on the initial disease burden level. Patients were grouped by disease severity at enrollment. Patients with severe disease were defined as those who required mechanical ventilation, took supplemental oxygen, had 94% or lower oxygen saturation as measured by pulse oximetry while they were breathing ambient air, or had a breathing rate of ≥ 24 breaths per minute. In this study, 159 (15.0%) patients were categorized as having mild-to-moderate disease, and 903 (85.0%) or the majority were in the severe disease group. Severe patients are the ones who had improvements with remdesivir. In the severe disease group, the median time to recovery was 11 days, as compared with 18 days. The benefit of the antiviral drug was larger when given earlier in the illness. Remdesivir did not, however, show significant improvements in moderately ill patients, and many doctors will likely remain cautious of using it in patients with less severe illness.

Clinical researchers are still trying to understand the full potential of remdesivir, in different settings and possibly as part of combination therapy. Given the high mortality in the treatment group, it is clear that treatment with remdesivir alone is not likely to be sufficient. NEJM authors shared that a variety of therapeutic approaches, such as new antivirals, modifiers of the immune response or other intrinsic pathways, and combination strategies are needed to continue to improve outcomes in Covid-19 patients. Gilead is also developing an inhaled version of the drug with the intent to use it outside of a hospital setting.

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