Leading drugmaker Merck recently applied to the U.S. FDA (Food & Drug Administration) for the approval of its antiviral pill molnupiravir to treat COVID-19.
Clearance for the drug would be a milestone in the fight against the Coronavirus, as it would be the first-of-its-kind pill to treat and control the widespread outbreak. For now, all other FDA-approved COVID-19 treatments involve an IV or injection.
Individuals would be able to take the COVID-19 pill at home to relieve symptoms and recover quickly, further reducing the burden on the U.S. hospitals and assisting in controlling the outbreak in nations with inadequate healthcare systems.
It would also support the pandemic's two-pronged approach, including treatment and prevention through vaccinations. However, before making a judgment, the FDA will examine the company’s data on molnupiravir's safety and effectiveness.
The drugmaker and its partner Ridgeback Biotherapeutic have urged the regulators to pass the pill for adults with mild-to-moderate COVID-19 who are at risk of severe disease or hospitalization. In this context, Dr. Nicholas Kartsonis, Senior VP with Merck's infectious disease unit, stated that the pill could eliminate the need to deal with infusion facilities and all the factors around that.
Merck had previously mentioned that the drug can reduce hospitalizations and fatalities in people with early COVID-19 symptoms by half. Observing the efficacy of the results, independent medical professionals have also recommended early deployment of the pill.
Patients who took the drug and those in a testing group who received a placebo experienced a similar side effect. Merck, on the other hand, has not publicized the aftereffects of the drug, which will be a major component in FDA's investigation.
NIAID Director, Dr. Anthony Fauci, speaking about Merck's pill, expressed it is better to prevent the infection than treating it. However, around 68 million eligible Americans still remain unvaccinated, underlining the need for effective medications to fight future outbreaks.
Pfizer and Roche are also testing similar medications and are likely to release results in coming weeks, sources cited.