- The Food and Drug Administration will authorize clinical trials of the malaria drug chloroquine for treating respiratory infections caused by the novel coronavirus as the agency seeks to aid the search for effective therapies.
- President Donald Trump, speaking Thursday at a press conference, also highlighted Gilead's experimental Ebola drug remdesivir as a potential "game-changer" as he sought to show the federal government is eliminating regulatory roadblocks to testing new treatments. Neither remdesivir nor chloroquine is approved to treat COVID-19.
- U.S.-based clinical work with chloroquine has been preceded by small Chinese and French studies, the latter of which suggested the pill could help clear the virus from the body.
With U.S. patient numbers quintupling in a week and testing still lagging behind demand, the White House's coronavirus task force has been eager to show it's taking action.
While Gilead's antiviral remdesivir was accelerated into clinical testing, chloroquine's emergence as a potential therapy has also given U.S. officials some hope for a cheap, generic drug regimen that can limit death and complications.
Bayer, maker of the chloroquine pill called Resochin, announced Thursday it is donating 3 million tablets to the U.S. government and is seeking an Emergency Use Authorization in treating coronavirus. Separately, the generic drugmaker Mylan announced it has restarted production of hydroxychloroquine sulfate, a form of the drug, at its plan in West Virgina.
Appearing at a White House press briefing, FDA Commissioner Stephen Hahn said the agency wants to make sure chloroquine is being used "in the setting of a clinical trial" to enable data collection. This was in contrast to Trump's statement that chloroquine had been "approved" for use in treating coronavirus.
"We'll be able to make that drug available by prescription," the president said. The FDA later confirmed no approval has been granted to any treatment for COVID-19.
A small French trial, results of which recently became available, tested 200 mg of hydroxychloroquine three times daily for 10 days, with a goal of detecting reduction in viral load. Among the 20 patients receiving the drug who completed treatment, 14 cleared SARS-CoV-2 from their bodies. Just 2 of the 16 patients in that study who did not receive the pill were cured at day six. Control patients either refused or were unable to take the drug.
Trump specifically cited work with remdesivir at the briefing, while Hahn mentioned treatments that involve infusing antibodies derived from recovered patients — so-called "convalescent plasma" — which is the approach taken by Takeda with its new experimental project TAK-888.
Hahn said these early approaches can serve as a short-term "bridge" to already-approved drugs that could receive a supplemental label to treat coronavirus infections, which in turn will keep death and complications in check until a vaccine can be proven safe and effective.
"This is a continuous process," he said. "There is no beginning or end to each of these [phases]."
Testing of a vaccine developed by the Cambridge, Massachusetts biotech Moderna began this week, while larger drugmakers Johnson & Johnson and Sanofi have speeded preclinical testing of their own candidates. Experts expect proving out a vaccine is safe and effective will take 12 to 18 months at minimum.