Gilead Expands Access to Potential COVID-19 Treatment, Remdesivir

Gilead will expand access to potential COVID-19 treatment, remdesivir, for patients with the greatest need, according to an official letter from Daniel O’Day, Gilead chairman and CEO.

For more coronavirus updates, visit our resource page, updated twice daily by Xtelligent Healthcare Media.

Gilead previously developed remdesivir to treat Ebola and when coronavirus first emerged, the company immediately began investigating the potential of the medicine against the novel coronavirus.

“Remdesivir had never been approved for use but based on what we had learned to date, we knew it might have potential with the novel coronavirus. Since then, we have been working with the greatest sense of urgency and responsibility to determine whether remdesivir does indeed work against COVID-19,” O’Day said in the letter.

Patients and providers are in desperate need of a COVID-19 treatment, so establishing the safety and efficiency of remdesivir is crucial. Although multiple studies are ongoing, Gilead will provide data as It becomes available in the coming weeks. Affordability and access to remdesivir is the priority, O’Day stressed.

This letter comes on the heels of a Gilead announcement late last week that it submitted a request to FDA to rescind the orphan drug status it was granted for remdesivir.

Gilead is waiving all benefits that accompany the designation. The pharmaceutical company voiced that it is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir without the orphan drug designation.

In early March, Gilead was granted an orphan drug designation for remdesivir as a potential treatment for COVID-19. FDA grants orphan drug designation in situation where the disease affects fewer than 200,000 patients.

This status results in a waiver of the requirement to provide a pediatric study plan before the submission of the New Drug Application, the announcement stated. This process can take up to 210 days to review.

Gilead noted that it will provide updates about the development of remdesivir as they become available. 

Expanding access ensures hospitals or physicians can apply for emergency use of remdesivir for severely ill patients and addresses the overwhelming application requests. “Expanded access” programs such as the compassionate use program will continue for children and pregnant women only in order to alleviate the strain on the healthcare system.

The approach will boost emergency access for more individuals. Initial sites in the US are up and running as of early this week, and it is expected that sites in additional countries will be activated soon

Remdesivir is a high-demand drug, with individuals reaching out to Gilead to request access to the drug on behalf of friends and loved ones. 

“I can only imagine how it must feel to be in that situation. We are used to seeing numbers and statistics in the news on a daily basis but we all know that behind each of those numbers is a real and often heartbreaking human story,” O’Day emphasized. 

“I speak for everyone at Gilead when I say how much we all wish we could help every patient in need. Today we are working at speed to establish the temporary expanded access programs, while at the same time establishing the potential safety and efficacy of remdesivir and determining for which patients remdesivir may have activity.”

O’Day highlighted that Gilead’s decisions are informed by guidance from public health authorities and bioethicists, as well as the company’s experience with previous antiviral drug developments for diseases including HIV and viral hepatitis. 

The company will continue to provide updates as the information becomes available.

“We hope that, in partnership with many groups around the world, we can play a part in helping patients with this disease. We know how much is at stake and the urgent need to determine whether remdesivir will be a safe and effective treatment.”