Gilead Receives US FDA Approval to Begin Clinical Trials of Inhaled Version of Remdesivir

(Foster City, CA, USA) has received the go-ahead from the US Food and Drug Administration (FDA Silver Spring, MD, USA) to begin trials of an inhaled version of its antiviral drug remdesivir in patients with COVID-19.

Remdesivir is presently being used to treat patients through emergency use authorizations and other access programs around the world. Currently, remdesivir is given to COVID-19 patients intravenously through daily infusions in the hospital. So far, randomized controlled trials of remdesivir have been evaluating its safety and efficacy in hospitalized patients. Data from these studies shows that remdesivir has the potential to be of meaningful benefit to patients with COVID-19.

As part of its next wave of clinical development, Gilead aims to study remdesivir in treating earlier in the disease, in combination with other therapies and in additional patient groups. The inhaled formulation studies are one means of exploring the use of remdesivir in the earlier stages of COVID-19. Gilead has begun screening healthy volunteers for Phase 1 trials for the inhaled version of its investigational antiviral medicine in COVID-19 patients to be conducted in August. An inhaled formulation would be given through a nebulizer, which could potentially allow for easier administration outside the hospital, at earlier stages of the disease which could help stem the tide of the pandemic.

“Without years of research on remdesivir, we would not have been able to move so quickly in response to this outbreak,” said Daniel O’Day, Chairman and CEO, Gilead Sciences, in an open letter. “We were able to rapidly enter into clinical trials because we already had sufficient knowledge from studying remdesivir in other viruses to hope it might work against COVID-19. Our commitment to remdesivir will continue now as we explore its full potential in the hope of helping many more patients with COVID-19.”

Related Links:
Gilead Sciences, Inc.
US Food and Drug Administration (FDA)