- The Food and Drug Administration has authorized the emergency use of two malaria drugs seen as potential treatments for COVID-19, allowing the federal government to begin distributing to states millions of doses donated by Novartis and Bayer.
- Chloroquine, and derivative versions like the two cleared by the FDA on Saturday, are decades-old generic medicines newly in the spotlight as the world races to test existing drugs for potential in treating COVID-19. No randomized clinical trial has proven the drugs to be effective, but observational studies in France and China have raised hopes of some benefit.
- President Donald Trump, in particular, has seized on chloroquine's potential, touting its "tremendous promise" and prematurely declaring the drug as approved 11 days ago. The FDA's emergency use authorization is not a standard approval, and limits use to only those patients who can't participate in a clinical trial or are ineligible.
The FDA's decision to grant an emergency approval for hydroxychloroquine sulfate and chloroquine phosphate is unusual, especially given the absence of randomized study evidence supporting the drug's use against COVID-19.
In its declaration, the agency cited "limited in vitro and anecdotal clinical data in case series," and noted the drugs' incorporation in several other nations' treatment guidelines.
One ongoing study, conducted by doctors in France, has been widely cited as suggesting a benefit to hydroxychloroquine, particularly when combined with the antibiotic azithromycin. The trial is small, enrolling only 80 patients, and lacks a control arm to more accurately measure whether the drug combination is actually helped patients recover from their coronavirus infection.
Another small study of 30 patients in China recently found hydroxychloroquine no better than a placebo, although the tiny sample size means it's similarly difficult to draw conclusions from the data.
Two larger, randomized clinical trials in New York and Minnesota are now underway, and could provide the needed evidence to better assess the benefit of chloroquine and its derivatives.
"FDA encourages the conduct and participation in randomized controlled clinical trials that may produce evidence concerning the effectiveness of these products in treating COVID-19," the agency's chief scientist, Denise Hinton, wrote in a letter authorizing the drugs' emergency use.
Trump, referring to the clinical study in New York, said on Sunday 1,100 coronavirus patients would receive hydroxychloroquine.
The president has emphasized speed, appearing to overrule health officials who caution that chloroquine and its other forms are not yet proven.
"There's reason to believe that it could be successful here," said Trump, responding to a reporter's question on that point in a Saturday press conference. "Now, the reason I disagree with you — and I think Tony would disagree with me — but the reason I disagree with you is that we have a pandemic," Trump added, referring to National Institute of Allergy and Infectious Disease Director Anthony Fauci.
Hydroxychloroquine sulfate is already approved by the FDA to prevent malaria infections, and to treat types of lupus and rheumatoid arthritis. The version of chloroquine phosphate granted emergency authorization is not approved, although other formulations are.
While the drugs' use in other diseases means physicians are familiar with its side effects, they are not completely safe and can cause heart rhythm and vision problems.
Doctors who prescribe the drug for lupus and arthritis have said they're encountering shortages, according to reports, now that the national spotlight is on the therapy's potential against COVID-19.
Physicians in the U.S. could already prescribe chloroquine-based drugs off label to patients infected by the new coronavirus, called SARS-CoV-2. A recent declaration by the Department of Health and Human Services also made immune from liability any healthcare professional prescribing or administering "covered countermeasures" against COVID-19.
But the emergency authorization by the FDA allows the U.S. government to distribute supplies of the two specified drugs from the Strategic National Stockpile. On Sunday, HHS accepted donations from Novartis and Bayer of, respectively, 30 million doses of hydroxychloroquine sulfate and 1 million doses of chloroquine phosphate.
Those supplies will now go to states through the Federal Emergency Management Agency.
Other companies, including Teva and Sun Pharmaceuticals, have announced donations of chloroquine formulations, while Mylan recently disclosed plans to restart manufacturing at its sprawling West Virginia plant.