Gilead halts ‘compassionate use’ of potential coronavirus drug
Gilead has said it has stopped accepting “compassionate use” requests for its potential coronavirus antiviral remdesivir because it cannot keep pace with demand as health systems become overwhelmed.
Remdesivir is seen as the best hope in the fight against the COVID-19 coronavirus, at least until a vaccine comes along and several trials are already under way.
But the US pharma said that it is facing huge demand for compassionate use requests for the drug, where the drug is given to severely ill patients as there are no approved treatment options that are effective.
California-based Gilead said there has been an “exponential increase” in compassionate use requests as the SARS-CoV-2 virus spreads across Europe and the US.
As a result this has “flooded” an emergency treatment access system set for very limited access to investigational drugs, and was never intended for use in response to a pandemic.
In response Gilead said it is moving existing individual compassionate use requests to an “expanded access” programme.
This will ensure these requests are met with a similar 72-hour timeframe to the compassionate use requests.
But the company will not accept new compassionate use requests, except for pregnant women and children aged under 18 with confirmed COVID-19 and severe symptoms.
Latest figures from the World Health Organization show the virus is still spreading rapidly throughout Europe and the US.
The data published on Sunday show 53,578 new cases in Italy, with 6,557 new cases, 4,827 deaths, and 795 new deaths.
Spain is badly hit with nearly 25,000 cases, 1,326 deaths, and 324 new deaths. In the US there are 15,219 cases, 201 deaths, but figures show no new cases or new deaths.
In China there are more than 81,000 confirmed cases, with 82 confirmed new cases and six new deaths, with 3,267 total deaths.
Gilead’s share price was down in premarket trading following the news, falling by more than $5, almost 7%, following the announcement.
Medical authorities in China last week said that a similar drug, favipiravir, developed to treat new strains of influenza appeared to be effective in coronavirus patients.
The Guardian reported that Zhang Xinmin, an official at China’s science and technology ministry said favipiravir had produced encouraging outcomes in clinical trials in Wuhan and Shenzhen involving 340 patients.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.