1.5 Million Doses of Experimental Coronavirus Drug Remdesivir Donated by Biotech Firm Gilead

A U.S. biotech company is donating 1.5 million doses of an experimental drug to treat COVID-19, the disease caused by the new coronavirus.

Daniel Day, CEO of Gilead, wrote on Saturday that the firm had 1.5 million individual doses of remdesivir in the final stages of production. Gilead is giving the whole of this existing supply to treat COVID-19 patients with the most severe symptoms, Day said.

Remdesivir, an anti-viral drug created for Ebola with promising results against MERS and SARS⁠, is among the experimental medicines which experts hope will be proven to be effective in treating COVID-19.

"The...doses are available for compassionate use, expanded access and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations," he wrote.

However, Day acknowledged that "remdesivir is still an investigational medicine and has not been approved by regulatory authorities anywhere in the world.

"The safety and efficacy are not yet known so while we feel the greatest sense of urgency in our work with remdesivir, we must take the responsible, ethical approach of determining whether it is indeed a safe, effective treatment. This is why multiple clinical trials for remdesivir are underway, involving thousands of patients with COVID-19 across the world."

Gilead is yet to confirm how long the drug should be used in patients in clinical trials, but it is thought the stock of 1.5 million doses could amount to 140,000 treatment courses. Remdesivir is administered through daily intravenous infusions in a hospital setting, according to the firm.

"Over the course of the past week, Gilead has been working in consultation with regulatory authorities to establish additional expanded access programs for remdesivir, our investigational medicine for COVID-19. The programs enable hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time," Day said.

Gilead would continue to give the drug "on an individual compassionate use basis for children and pregnant women. More than 1,700 patients have now been treated through these programs," according to the update.

This comes after the company last week announced it would be changing how the experimental drug was distributed "due to an overwhelming demand." Gilead said in a statement that while clinical trials are the "primary way" to access remdesivir, severely ill patients cannot enrol.

The company had previously given "several hundred" patients in the U.S., Europe and Japan emergency access to the medicine. But due to an "exponential increase" in compassionate use requests as the virus spread in Europe and the U.S., the company decided to stop granting them on an individual basis. Instead hospitals or physicians have to apply for emergency use for "multiple severely ill patients at a time."

Gilead has started two phase 3 clinical trials to study how safe and effective remdesivir is in adults with COVID-19, which it hopes to complete in May, according to ClinicalTrials.gov, a registry of clinical trials run by the United States National Library of Medicine at the National Institutes of Health.

The company hopes to produce more than 500,000 treatment courses by October, and more than one million by the end of 2020, Day said.

There is currently no specific drug or vaccine approved for use to treat COVID-19. Antimalarial drugs chloroquine and hydroxychloroquine are also being investigated by scientists around the world. And last month the World Health Organization (WHO) launched a multi-country clinical study of four potential combinations including remdesivir and chloroquine.

Since the COVID-19 pandemic started in China late last year, the new coronavius has spread to almost every continent and territory in the world, as shown by the Statista map below. More than 1.2 million cases have been confirmed, a total of 69,514 people have died, and almost 263,000 people have recovered, according to Johns Hopkins University.