Drugmaker It was announced Monday that Merck had requested approval for its COVID-19 tablet, which would bring a completely new and simple-to-use weapon to a world’s arsenal of weapons against the pandemic if approved.
If approved by the FDA, which may happen in a matter of weeks, this would be the first medication to be proven to be effective in treating COVID-19 in humans. All other FDA-approved therapies for the illness need administration via an IV or injection.
Merck Has Requested To The US FDA For A Promising Anti Covid Pill
It is possible that an antiviral tablet that patients may take at home to lessen their symptoms and hasten recovery would be revolutionary, alleviating the crushing caseload in U.S. hospitals and aiding in the containment of epidemics in poorer nations with inadequate healthcare systems.
It would also strengthen the two-pronged strategy to combating the pandemic: treatment, which would include medicine, and prevention, which would consist of vaccines, among other things.
Before making a decision, the FDA will review corporate data on the medication, molnupiravir, to ensure that it is both safe and effective for patients.
In a statement, Merck and its partners Ridgeback Biotherapeutic stated they explicitly requested that the FDA give emergency use authorization for individuals with fairly benign COVID-19 who are at risk of severe illness or hospitalization. That is about how COVID-19 infusion medicines are administered.
The firm said earlier in the month that the tablet reduced hospitalizations and fatalities among people with acute signs of COVID-19 by half when compared to a control group. The findings were so compelling that those independent medical professionals overseeing the study advised that it be terminated early.
Patients who took the medication had side effects that were comparable to those seen by individuals in a testing group that received a fake tablet. However, Merck has not disclosed the specific kinds of issues that have been documented, which will be an essential element of the FDA’s investigation.
Officials in the United States continue to promote vaccines as the most effective method of protecting against COVID-19. However, with about 68 million qualified Americans still refusing to receive the injections, effective medicines will be essential in preventing future outbreaks of illness.
Since the beginning of the epidemic, health professionals have emphasized the need to have an accessible medication to take. Three FDA-approved antibody medicines have been shown to be very successful in decreasing COVID-19 fatalities; however, they are costly, difficult to manufacture, and need specialized equipment and health experts to be delivered to recipients.
In the event that the Food and Drug Administration approves the tablets, the United States government has committed to purchase enough of them to treat 1.7 million patients at the cost of about $700 per course of therapy. That’s or less half the price of antibody medicines bought by the United States government at the cost of more than $2,000 each infusion. However, it’s still more costly than many antiviral tablets used to treat other diseases. The drug’s manufacturer, Kartsonis, stated in an interview that now the $700 number does not reflect the ultimate cost of the medicine.