FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment

Since the onset of the COVID-19 pandemic, the Food and Drug Administration (FDA) has worked alongside researchers and innovators with the collective aim of protecting public health. As new treatments are developed, the goal of the administration is to weigh the benefits of these treatments against their potential risks and, if the outcome is favorable, expedite their availability and save as many lives as possible. 

On May 1st, the FDA issued an emergency use authorization (EUA) for the drug Remdesivir for the treatment of adults and children hospitalized with severe COVID-19. In a clinical trial by the NIH, only two days prior, Remdesivir was found to shorten recovery time for patients from 15 to 11 days. Remdesivir is far from a cure — instead, it was found to relieve symptoms and improve recovery time, similarly to how Tamiflu acts against the influenza virus. 

An EUA isn’t the same as full FDA approval. EUAs allow the FDA to act quickly in the face of a public health emergency. As it stands, no alternative is available for the treatment of COVID-19. Given that Remdesivir has shown promising preliminary results from a placebo-controlled clinical trial, the FDA has decided to endorse its distribution and use to bring down the number of life-threatening COVID-19 cases.

It’s important to note that the safety and efficacy of Remdesivir in its treatment of COVID-19 continue to be evaluated in ongoing clinical studies. The results and conclusions of these trials will determine whether the drug is safe and effective against the virus. Additional studies have yet to be executed to investigate the drug’s effects in special populations (such as pregnant women) or people with underlying conditions or complications. 

First Authorized Therapy Drug for COVID-19 in the U.S.

The EUA for Remdesivir permits its distribution and intravenous administration by healthcare providers in severe cases of COVID-19 (including patients who require intensive breathing support such as a mechanical ventilator). Fact sheets offering detailed instructions on dosing and a list of the potential side effects and drug interactions have been made available to both healthcare providers and patients. 

The potential side effects of Remdesivir include increased liver enzymes, which may be indicative of liver damage or inflammation.

Infusion-related reactions include vomiting, sweating, and shivering, among others. Emphasis is placed on Remdesivir as an investigational drug whose potential risks remain unknown. Likewise, the optimal dosing for the drug is not clear, but the biopharmaceutical company behind Remdesivir, Gilead Sciences, recommends that patients on ventilators be treated for ten days while non-ventilator patients for five days. 

Accelerated Production

In anticipation of results determining whether Remdesivir is safe and effective, Gilead has expedited manufacturing timelines to maximize the availability of the drug as quickly as possible. The company has donated its existing supply consisting of 140,000 treatment courses and have set a goal of manufacturing half a million courses by October, and 1 million by December. If necessary, Gilead expects to produce several million treatment courses in 2021. 

Growing Importance of Education and Training

As the situation evolves with each passing day, businesses across industries must make an effort to keep staff informed and adequately trained. The Center for Professional Innovation and Education (CfPIE) continues to provide updated pharmaceutical training and certification programs to professionals across industries. 

In the face of social distancing and stay-at-home orders, we’ve adapted our education modules to offer specialized online learning options. 

We recommend the following courses for staying up-to-date with the development of COVID-19 treatments:

• The Drug Development Process from Concept to Market
• Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products

Are you interested in our pharmaceutical and biotech training programs? Contact CfPIE today by calling 1-610-648-7550 if you’d like to learn more.