Ridgeback Biotherapeutic, the drugmaker, and Ridgeback Biotherapeutic, its partner, stated that they asked FDA for authorization to emergency treat adults in mild-to-mode cases who may become seriously ill or need hospitalization.
Mexico City (apro).- On Monday, the U.S. Food and Drug Administration received from Merck (Merck), a request to authorize the emergency use of its drugs in covid-19.
Merck’s oral vaccine is the first to be administered. This is in contrast to licensed vaccines, which can only be injected or given intravenously. This pill can decrease the risk of death up to 50%
The FDA will examine the data provided by the company regarding the safety and effectiveness monoprevir before making a final decision.
Merck and Ridgeback Biotherapeutic, Ridgeback’s partner, said that they demand that the FDA authorize emergency treatment for adults in mild-to-mode cases who may be hospitalized or become seriously ill. These are similar to intravenous drug use.
“The benefit here is that it’s a pill so the infusion centre does not have to address all relevant factors,” Dr. Nicholas Kartsonis from Merck’s infectious diseases department, said. “I believe this is a powerful tool that could be added to our arsenal.”
This month, the company reported that Covid-19’s pill had roughly reduced the deaths and hospitalizations of patients who were suffering from the first symptoms. The trial’s results were so evident that independent medical experts who reviewed it recommended ending the trial immediately.
Side effects suffered by patients who took the drug were comparable to those experienced by those who took a placebo. Merck has not yet made public the issue, which could have played a significant role in FDA’s decision.
(Includes AP information)