The novel coronavirus pneumonia Reed is expected to expand in the treatment of new crown pneumonia in the United States after the emergency authorization of FDA. On May 1st, novel coronavirus pneumonia was issued by Reed for the treatment of new crown pneumonia by FDA. (EUA). According to the statement, geride science, R & D company of Ridgeway, hospitals with ICU in the United States will be able to give priority to Ridgeway.
On May 1, Gillied issued a statement saying the emergency use of authorization will promote the more widely used treatment of newly-crowned pneumonia patients admitted to hospital, so that more hospitals across the United States to obtain Rhettsivir. At present, the distribution of the limited supply of Rhettsivir will follow the guiding principles, with the guidance and cooperation of the Government, to maximize the availability of suitable patients in need of treatment.
Gillied said the U. S. government will coordinate the donation and distribution of Redseave to the city hospitals with the most severe new coronary pneumonia. Because of the severe condition of patients suitable for the use of Rhettsivir and the limited availability of drugs, hospitals with intensive care units (ICU) and other hospitals that the Government considers most needed will be given priority to the allocation of Rhettsivir. Gillied is working with the U.S. government on distribution logistics for Redsea and will provide more information when shipping starts under emergency use authorization.
The statement said that the authorization for emergency use is temporary and cannot replace the formal procedures for submission, review and approval of new drugs.
"Emergency use authorization opens the way for us to provide more emergency use for new critically ill patients with coronal pneumonia ," Daniel O Gillied Scientific Chairman and CEO
O'Day also told the media at the White House launch that Gilead would donate 1.5 million doses of radcivir.
After obtaining the authorization for emergency use, Gilead can cooperate with the government to directly transport radcivir to the most needed hospital. On May 1, a spokesman for Gilead said that in the United States, the federal government can decide where to distribute the donated drugs based on the cities with the largest demand shown by epidemiological data.
Redceway is already speeding up production.
Daniel O'Day said in a statement on april 29th that "the geely team has accelerated production since january, given the constraints of long and complex production processes ."
Daniel O'Day said, "including finished products waiting to be distributed and preparations in the final production stage, we have a total supply of 1.5 million doses. We estimate that these will be used for 140000 10 day courses. If we can shorten the course of treatment for severe patients, we can significantly increase the number of courses covered by these drugs that Gilead has promised to donate. "
Since novel coronavirus pneumonia has not yet been effective, Reed cilavir has been used in a small number of patients with sympathy medication, which is donated by Gillie.
The US FDA's emergency use authorization limits the use of the drug, i.e. it is only approved during the new crown outbreak, but if a large study and other clinical trials of the National Institute of allergy and infectious diseases (NIAID) can prove that the drug has more benefits, the health regulatory authorities may also give full approval and authorization.
Ridcivir, once considered the most promising drug against the new coronavirus, was developed by Gilead science, based in California, USA. Radcivir has shown some promise in the treatment of SARS and mers, both of which are caused by coronaviruses.
Novel coronavirus pneumonia is a new novel coronavirus pneumonia treatment system. FDA said in a statement that the emergency use authorization is used to treat suspected or laboratory confirmed adult and child patients with severe acute respiratory syndrome. "Although limited information is available on the safety and efficacy of Reed's new treatment for hospitalized patients with new crown pneumonia, the study shows that the research drug can shorten the recovery time of some patients."
FDA introduced the novel coronavirus pneumonia authorization system, which allows Reed to distribute in the US and is administered intravenously by medical staff to treat suspected or laboratory confirmed adult and new severe pneumonia patients. Severe refers to patients with low blood oxygen level or need more intensive respiratory support (mechanical ventilator) such as oxygen therapy.
Earlier, novel coronavirus pneumonia patients had just reported positive results, which indicated that the drug effectively reduced the recovery time of patients with new crown pneumonia.
On April 29, the director of the National Institute of allergy and infectious diseases (NIAID) fudge said that radcivir showed efficacy in a randomized double-blind controlled trial of NIAID, which can moderately speed up the recovery of patients with new coronavirus infection.
The trial recruited 1,063 new-crown pneumonia patients from several countries around the world. Initial results showed that the median recovery time in the Rhettcivir treatment group was 11 days, compared with 15 days in the placebo control group, and the recovery time in the Rhettcivir treatment group was 31% faster than that in the placebo control group (p)
"Speeding up your recovery by 30% doesn't sound as attractive as 100% healing." "But it's a very important piece of evidence because it's already proven that radcivir can block the new coronavirus," Fauci said