Gilead halts emergency access to remdesivir in Covid-19 indication

Gilead Sciences has announced a temporary halt to emergency access to its investigational Covid-19 drug remdesivir due to rising demand.

The antiviral drug is currently being assessed in several clinical trials for treating the novel coronavirus infection.

For patients unable to participate in studies, the company has been working with regulators to offer emergency access to the drug.

Gilead noted that several hundred patients had been provided emergency access to remdesivir across the US, Europe and Japan.

However, a recent surge in Covid-19 cases in the US and Europe led to an ‘exponential increase’ in compassionate use requests, added the company.

The company is switching from a system of individual compassionate-use requests to expanded access programmes to improve access to the drug for severely ill patients, as well as gather data from all participants.

Gilead will not accept new compassionate use requests during the transition period but will process previously approved requests. Exceptions will be made for pregnant women and children aged below 18 years with severe Covid-19 infection.

In a statement, the company said: "Enrolment in clinical trials is the primary way to access remdesivir to generate critical data that inform the appropriate use of this investigational medicine.

"We recognise the urgent need and are working to implement expanded access programmes as quickly as possible, with the continued support and collaboration of regulatory agencies."

In February, the US National Institutes of Health (NIH) reported that remdesivir prevented the Middle East respiratory syndrome coronavirus (MERS-CoV) disease when administered in monkeys before infection, improving their condition after infection.

Gilead Sciences is an American biotechnology company that researches, develops and commercialises drugs, focusing primarily on antivirals to treat HIV, hepatitis B and C, as well as influenza.

Register as Visitor to CPhI China 2020!

-----------------------------------------------------------------------
Editor's Note:

En-CPhI.CN is a vertical B2B online trade platform serving the pharmaceutical industry,

for any copyright disputes involved in the articles,

please email: Julia.Zhang@imsinoexpo.com to motify or remove the content.