Despite reams of data from an international WHO study raising serious questions about its efficacy, the FDA has finally approved the use of Gilead Science's remdesivir - a powerful antiviral originally developed to treat ebola - for the treatment of COVID-19, making it the first such drug approved to treat the virus in the US.
The FDA first granted the drug emergency authorization in May, allowing hospitals and doctors to use the drug even though by all accounts it wasn't that widely used.
President Trump received one course of remdesivir along with several other COVID-19 therapies after contracting the virus. Doctors also gave the president dexamethasone, a steroid that has a much better track record for treating the virus, according to the available data. Trump also received an experimental drug from Regeneron, which, along with Eli Lilly, has filed for emergency use approval for its COVID-19 antibody treatment.
Gilead has been waging a PR campaign against the WHO, which recently publicized the results of its global trial of remdesivir, producing data that was widely hailed as definitive by other scientists.
But Gilead had a lock on approval seemingly from the very beginning, as US officials, including Dr. Anthony Fauci, praised the drug. Dr. Fauci once said the drug would "set a new standard of care" for COVID-19.
Back in August, Gilead said the company planned to produce more than 2 million courses of the drug by the end of the year, with "several million more coming in 2021."
Initially, Gilead says it will initially focus on meeting "real-time demand" in the US.
Oddly, none of the initial coverage of the FDA's decision included much discussion of the WHO's trial data, which pretty clearly branded the drug a flop. Even the evidence that Gilead has managed to marshal in remdesivir's defense has been pretty unconvincing.