According to US media reports, Merck has filed an emergency approval application for its oral COVID-19 drug in the United States.
According to US media reports, drug maker Merck asked local regulatory authorities (FDA) on Monday to approve the COVID-19 pill. This, according to the Associated Press, “will add entirely new and easy-to-use weapons to the global arsenal against the pandemic.”
A decision can be made within a few weeks. The FDA will carefully review the company’s data on the safety and efficacy of the drug, molnupirarva, before making a decision, AP reports.
Merck announced earlier this month that the pill has halved hospital admissions and deaths among patients with early symptoms of COVID-19.
Side effects were similar between patients who took the drug and patients in the test group who took the pacifier. But Merck hasn’t publicly disclosed the types of issues that have been reported, which will be a key part of the FDA’s review.
Since the outbreak of the pandemic, health experts have emphasized the need for a convenient tablet, according to US media reports. They emphasize that the goal is to create something akin to Tamiflu, a 20-year-old flu cure that cuts illness by a day or two and relieves symptoms such as fever, cough and nasal congestion.
In early October, Merck announced that it would be applying for an emergency license in the United States, and would also seek regulatory approval in other parts of the world.
Molnupiravir is administered orally and stops the replication of the coronavirus in the body.
AstraZeneca tries too
Experimental COVID-19 drug AstraZeneca (AZN.L) helped reduce the risk of serious illness or death in the late-stage study, according to Reuters.
The drug, a mixture of two antibodies called AZD7442, was expected to reduce the risk of severe COVID-19 or death by 50 percent. in non-hospitalized patients with symptoms lasting seven days or less consistent with the primary objective of the study.