In a much-anticipated press conference Thursday, President Donald Trump said the U.S. has stepped up near-term efforts to advance and make available antivirals to help patients with COVID-19 illnesses.
But despite the urgency and the progress, FDA commissioner Stephen Hahn said it’s important to learn more about all potential treatments.
Amid the pandemic, one drug that’s gained attention in various countries is chloroquine, a decades-old malaria med that’s available for cheap. President Trump said the U.S. is going to make the drug available by prescription “almost immediately.”
Chloroquine is already approved to treat malaria, and Hahn said investigators are planning a “large, pragmatic clinical trial” to learn more. But, the commissioner cautioned, it’s always important to get the “right drug” to the “right patient” at the “right dosage” at the “right time.” The wrong dose could actually hurt a patient’s condition, he added.
While chloroquine isn’t approved for patients with novel coronavirus infections, Trump may have been referencing an off-label use for the medicine. It wasn’t immediately clear how the drug would become available imminently.
Aside from chloroquine, the president and FDA commissioner Hahn talked about efforts to test Gilead’s remdesivir, originally developed for Ebola. Trump said that drug is “very close to approved,” but Hahn declined to specify potential approval timelines.
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Other efforts are underway for plasma-based therapies and repurposing existing medicines, Hahn said at the press conference.
Meanwhile, investigators have launched a vaccine trial “in record time,” the president said. It’ll be 12 months before the study completes and the FDA could potentially approve the shot, Hahn said.
Until then, the antivirals and other drugs are intended to be a “bridge” for treatment until the medical community has a deployable vaccine, Hahn added.
By Eric Sagonowsky
Source: Fierce Pharma
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