The comments came soon after the publication of peer-reviewed final figures from a large-scale trial of the Guild of Redevsvir. It was shown that the antiviral drug helped Kovid-19 patients, who are treated on average five days faster in hospitalization. For critically ill patients who received Remedisvir, recovery accelerated for seven days.
O’Day said, “These results are worthwhile. They will certainly help patients around the world who have the misfortune to enter the hospital, and do better, and I am happy to say that we have enough Supply. ” Box.”
The study, published in the New England Journal of Medicine, also found that Remedisvir contributed to a significant reduction in mortality for patients who were in the early stage of receiving oxygen support. In the study, however, the trial did not find a statistically significant mortality reduction in 1,060 patients.
“The treatment you get earlier is better in the hospital and you can prevent people from going through those stages of the disease where the risk of dying is very high,” O’Day said. “It is a drug that works by reducing viral replication in the body, which is important before the disease and before your hospital stay, which is why it has the greatest effect there.”
Remedisavir is administered in a hospital setting via IV. Gilead is working on creating an inhaled version.
Former FDA Commissioner Dr. Scott Gottlieb later stated on the “squawk box” that the study’s results were “strong.”
“They confirm what we knew, which is active in the disease,” he said. “It is not a homegrown drug. It is a weakly active antiviral, but has a healing effect, so it is worthwhile.”
Gottlieb, who served at Trump, said, “I think the antibodies combined with the drugs should be based on data coming to market soon, which is one of the more effective treatments we’ve seen for the vaccine.” . ” Administration from May 2017 to April 2019.
The drug received emergency use approval from the Food and Drug Administration in May as a treatment for critically ill Kovid patients. In late August, the FDA expanded the authority to include all hospitalized coronovirus patients. Regulators in nearly 50 countries have approved that Remedisvir has Kovid-19 treatment.
The drug was one of several infections after President Donald Trump announced it last Friday. In addition to remedisavir, Trump received an experimental antibody cocktail from Regeron Pharmaceuticals and the steroid dexamethasone.
In a White House video released on Wednesday evening, Trump called the Regeneron treatment a “cure,” although the company has only released preliminary data showing its potential effectiveness.
Regeneron has applied to the FDA for Emergency Use Authorization for its antibody cocktail. Eli Lilly has also submitted an emergency use application with the FDA for his antibody drug.
Gottlieb told CNBC on Friday that he believed those treatments would be approved for emergency use. Antibody treatments work differently than Remedisvir. Instead of preventing the virus from recurrence, antibody drugs attach to the existing virus and try to neutralize it.
“These two mechanisms can really be complementary and we’ll study them,” O’Day said. “We’re going to be very clever. … In six months, 12 months, we’re going to be able to fix this kind of therapeutic paradigm and vaccine paradigm for the best benefit of patients.”
– Reuters and The Associated Press contributed to this report.
Disclosure: Scott Gottlieb is a CNBC contributor and a board member Pfizer, Genetic testing start-up temps and biotech company Illumina. Pfizer has a manufacturing agreement for Remedivir with Pfizer. Also serves as co-chairman of Gottlieb Norwegian Cruise Line Holdings‘And Royal Caribbean“Healthy Cell Panel.”