US regulators on Friday allowed emergency use of the first drug that appears to help some COVID-19 patients recover faster, a milestone in the global search for effective therapies against the coronavirus. The Food and Drug Administration cleared Gilead Science’s Remdesivir for hospitalised patients with “severe disease,” such as those experiencing breathing problems requiring supplemental oxygen or ventilators.
As per the letter sent from the FDA to Gildead approving the Emergency Use Authorisation, “On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19.1 On the basis of such determination, the Secretary of HHS on 27 March, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biologics during the COVID-19 outbreak, pursuant to section 564 of the Act, subject to terms of any authorization issued under that section.”
The letter further stated, “Remdesivir is a direct acting antiviral drug that inhibits viral RNA synthesis. It is an investigational drug and is not currently approved for any indication. Remdesivir has activity in cell culture and animal models against SARS-CoV, MERS-CoV, and SARS-CoV-2.”
“Based on review of the topline data from the randomized, double-blinded, placebo-controlled trial conducted by NIAID (NCT04280705) and from the Gilead-sponsored open-label trial that evaluated different durations of remdesivir (NCT04292899), it is reasonable to believe that the known and potential benefits of RDV outweigh the known and potential risks of the drug for the treatment of patients hospitalized with severe COVID-19. Having concluded that the criteria for issuance of this authorization under 564(c) of the Act are met, I am authorizing the emergency use of remdesivir for treatment of COVID-19,” the letter stated.
The FDA acted after preliminary results from a government-sponsored study showed that the drug, Remdesivir, shortened the time to recovery by 31 percent, or about four days on average, for hospitalized COVID-19 patients. Those given the drug were able to leave the hospital in 11 days on average vs. 15 days for the comparison group. The drug may also help avert deaths, but that effect is not yet large enough for scientists to know for sure.
As per the letter, the FDA stated that “Remdesivir for injection, 100 mg, vials should be stored below 30 °C until time of use. Remdesivir injection, 5 mg/mL vials should be stored at refrigerated temperatures (2 °C to 8 °C) until time of use. Following dilution with 0.9 percent saline, the solution can be stored for up to 4 hours at room temperature (20 °C to 25 °C) or 24 hours at refrigerated temperatures (2 °C to 8 °C).”
President Donald Trump announced the news at the White House alongside Gilead CEO Daniel O’Day and Food and Drug Administration Commissioner Stephen Hahn. “This was lightning speed in terms of getting something approved” said Hahn, calling the drug “an important clinical advance.”
Dr Sameer Khanijo, a critical care specialist, said he wants to see additional studies to clarify the drug’s benefit.
“I don’t think this is a cure yet, but I think it’s starting to point us in the right direction,” said Khanijo of North Shore University Hospital in New York. “As a society it’s nice to have something that will help stem the tide of this disease.” The FDA said preliminary results from the government study warranted Friday’s decision, though regulators acknowledged “there is limited information known about the safety and effectiveness of using Remdesivir.”
The drug’s side effects include potential inflammation of the liver and problems related to its infusion, which could lead to nausea, vomiting, sweating and low blood pressure. Information about dosing and potential safety issues will be provided to physicians and patients, the FDA said.
The National Institutes of Health’s Dr Anthony Fauci said Wednesday the drug would become a new standard of care for severely ill COVID-19 patients. Remdesivir, which blocks an enzyme the virus uses to copy its genetic material, has not been tested on people with milder illness.
The FDA authorised the drug under its emergency powers to quickly speed the availability of experimental drugs, tests and other medical products during public health crises.
In normal times the FDA requires “substantial evidence” of a drug’s safety and effectiveness, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can waive those standards and require only that an experimental treatment’s potential benefits outweigh its risks.
Gilead has said it will donate its currently available stock of the drug and is ramping up production to make more. It said the US government would coordinate distribution of Remdesivir to parts of the country that need it most.
No drugs are currently FDA-approved for treating the coronavirus, and Remdesivir will still need formal approval. The FDA can convert the drug’s status to full approval if Gilead or other researchers provide additional data of Remdesivir’s safety and effectiveness.
“This is a very, very early stage so you wouldn’t expect to have any sort of full approval at this point,” said Cathy Burgess, an attorney specialising in FDA issues. “But obviously they want to get this out to patients as quickly as possible.”
The FDA previously allowed narrow use of a malaria drug, hydroxychloroquine, for hospitalised patients who were unable to take part in ongoing studies of the medication. Trump repeatedly promoted it as a possible COVID-19 treatment, but no large high-quality studies have shown the drug works for that and it has significant safety concerns.
The FDA warned doctors late last month against prescribing the drug outside of hospital or research settings, due to risks of sometimes fatal heart side effects. The agency made the announcements after receiving new reports of injury and death with the medication, which is also used to treat lupus and rheumatoid arthritis.
Two small studies published Friday add to concerns about hydroxychloroquine. Critically ill COVID-19 patients given the pill-based drug were prone to heart rhythm problems, and for many risks mounted when it was combined with an antibiotic, the studies found.
With inputs from AP