from the Intercept article from today:
Gilead abruptly announced that it would no longer provide emergency access to remdesivir, telling the New York Times that "overwhelming demand" left it unable to process requests for the drug through its compassionate use program. Hours later, the FDA gave the drug orphan status. Almost immediately, Gilead's stock price shot up. Gilead did not immediately respond to a request for comment. The White House, on behalf of Grogan, declined to comment on the record.
The special orphan designation, which can also be granted to drugs when there is little reasonable expectation that a company will recoup its research costs, was given to remdesivir despite hefty support by the government for the development of the drug.
Gilead Sciences' remdesivir was developed with at least $79 million in U.S. government funding, according to a paper published last week by KEI. The origins of the drug came after the 2014 Ebola outbreak in western Africa, which spurred research into potential antiviral medications to control future potential pandemics. Early promising results from the U.S. Army Medical Research Institute of Infectious Disease revealed that Rhesus monkeys infected with Ebola survived after undergoing an antiviral treatment using GS-5734, the compound now known as remdesivir.
The U.S. National Institute Allergies and Infectious Diseases continued providing significant taxpayer funding to subsidize the development of remdesivir. NIAID grants to Columbia University, Vanderbilt University, University of North Carolina-Chapel Hill, and the University of Alabama subsequently found that remdesivir prevents virus replication in a range of coronaviruses in human lung cells.
Although the Orphan Drug Act was designed to solve a real problem a lack of treatments for uncommon illnesses pharmaceutical companies have for years exploited it for gain. Rather than treating AIDS or HIV infection, drugs were framed as treating diarrhea or tuberculosis in HIV-infected people, thus narrowing their scope. And companies have extended their exclusive marketing rights by repurposing drugs that are already patented for other purposes to treat rare diseases. Orphan drugs now generate more than $100 billion in annual sales, and even though companies are increasingly using the law, more than 90 percent of rare diseases lack treatments approved by the FDA.
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Trump announced Thursday that the Food and Drug Administration would soon introduce new coronavirus therapies.
Trump announced that the FDA is "slashing all of the red tape" to get medicines on the market "as fast as we can get it." Anti-viral therapies are still in early clinical trials, but the Trump administration is aiming to speed up the process.
"What the FDA is doing is incredible," Trump said. "I've directed the FDA to eliminate outdated rules and bureaucracy. ... We have to remove every barrier."
Another drug that could be used to treat the coronavirus is Remdesivir, an antiviral made by Gilead, the manufacturer behind PrEP drugs to prevent HIV infection.
"We need to make sure that the sea of new treatments will get the right drug to the right patient at the right dosage at the right time," said the FDA commissioner, Dr. Stephen Hahn.
Though the drugs have been approved for other specific treatments, the FDA is working to see if expanded use is possible.
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