FDA Pipeline: EUA Granted for Plasma, Remdesivir Expands to Moderate Cases

A refresher on the week's developments in the infectious disease drug & medical device FDA approval pipeline.

FDA Grants Emergency Use to Convalescent Plasma for COVID-19

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the use of convalescent plasma in treating coronavirus 2019 (COVID-19).

The authorization comes after a week of cyclical debate among public health officials and legislators, as well as clinical appraisal among investigators—which have both come to highlight most agents granted emergency authorization by the FDA.

In a release Sunday evening, the FDA stated its decision is based on available scientific evidence indicating convalescent plasma may be beneficial for COVID-19, and that the known and potential product benefits outweigh its understood risks.

“Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing,” the FDA stated.

In a statement accompanying the decision, FDA Commissioner Stephen Hahn, MD, expressed encouragement from “early promising data” for convalescent plasma.

“The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” Hahn said. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”

Full story.

Remdesivir Receives EUA for Patients With Moderate COVID-19

The FDA today announced it had expanded its Emergency Use Authorization (EUA) for remdesivir (Veklury) enabling its use to treat all hospitalized patients with coronavirus 2019 (COVID-19).

Previously, the last EUA for the medication issued back in May only included he treatment of hospitalized patients with severe COVID-19.

“With the growing understanding of the utility of Veklury to help improve outcomes for a range of patients with COVID-19, we welcome the FDA’s decision to expand emergency use authorization,” Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, said. “As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease. Today’s action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury.”

The expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating remdesivir in hospitalized patients with moderate COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity.

Full Story.