Gilead Sciences Inc., a U.S. biotechnology firm that develops and commercializes drugs, has rapidly expanded its supply of an experimental coronavirus drug and is prepared to donate 1.5 million doses of it to hospitals dealing with severely ill patients.
Gilead CEO Daniel O'Day said in a statement Saturday that the 1.5 million doses of the drug, known as remdesivir, could be part of treatment courses for as many as 140,000 patients. He said the doses were available for "compassionate use, expanded access and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations."
He also noted that the drug would be offered free of charge to hospitals or physicians who apply for its emergency use. Remdesivir remains an experimental drug without regulatory approval.
"In the ways we believe it is appropriate for Gilead to play a role today - primarily through clinical trials, as well as expanded access and compassionate use - we are doing everything it takes to meet our significant responsibility with remdesivir," O'Day wrote.
The company is working to produce more than 500,000 treatment courses by October and more than 1 million by the end of 2020, O'Day added. He noted that the manufacturing timeline was reduced from about one year to six months.
There are no approved treatments for COVID-19, the illness caused by the novel coronavirus. There are also "many unknowns" about remdesivir's safety and effectiveness, O'Day acknowledged.
"We made the decision to invest and scale up regardless, because if remdesivir was going to be needed for patients, we had to be ready," he said, noting that the drug would be available for treating individuals with the most severe COVID-19 symptoms.
The novel coronavirus, which originated in China in December, has infected more than 312,000 people in the U.S., according to a Johns Hopkins University database. Several U.S. companies are reportedly involved in the development of treatments for the virus.
The Food and Drug Administration has also issued an emergency-use authorization for a pair of anti-malaria drugs that President TrumpDonald TrumpSenate rejects attempt to block Biden's Saudi arms sale Crenshaw slams House Freedom Caucus members as 'grifters,' 'performance artists' Senate confirms Biden's nominee to lead Customs and Border Protection MORE has repeatedly touted.
The drugs will be "distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible," the Department of Health and Human Services said. Health officials have regularly warned that not enough is known about the drugs to offer any definitive conclusion about their effects.