Merck Requests Emergency Authorization For First COVID-19 Pill
By Jason Hall
October 11, 2021
NBC News reports the New Jersey based company asked U.S. regulators to authorize the pill on Monday (October 11) which, if approved, would be the first pill shown to treat the coronavirus, as all previous FDA-backed treatments have required an IV or injection.
An antiviral pill capable of being taken at home could possibly limit the spike in hospitalizations and outbreaks in poorer countries with weak health care systems as COVID-19 patients, as well as provide an a treatment by medication to go along with the prevention through vaccinations.
The FDA will analyze data provided by the company to determine whether the drug, molnupiravir, is safe and effective before making its decision.
Merck and its partner, Ridgeback Biotherapeutic, said they have specificially requested emergency approval for the use of its drug in adults with mild-to-moderate COVID-19 facing a risk for severe disease or hospitalization, which is typically how infusion drugs have been used in the past, NBC News reports.
“The value here is that it’s a pill so you don’t have to deal with the infusion centers and all the factors around that,” said Dr. Nicholas Kartsonis, a senior vice president with Merck's infectious disease unit. “I think it's a very powerful tool to add to the toolbox.”
Earlier this month, the company claimed the pill led to a decrease in hospitalizations and deaths among half of patients with early symptoms of COVID-19 during its case study.
The results were show strong that independent medical experts monitoring the tests recommended the company complete its trials earlier than originally planned.
Side effects for the pill were similar to those who received a dummy pill during the tests, but Merck did not publicly specify the types of problems reported, which will be a major factor in the FDA's review of the drug.