It has been reported that U.S. regulators have authorized a second pill against COVID-19, an antiviral drug from Merck that may help blunt the wave of infections driven by the omicron variant.
U.S. health regulators on Thursday authorized the second pill against COVID-19, providing another easy-to-use medication to battle the rising tide of omicron infections.
The Food and Drug Administration announcement on Merck’s molnupiravir comes one day after the agency cleared a competing drug from Pfizer.
Pfizer’s pill, Paxlovid, is likely to become the first-choice treatment against the virus, because of its superior benefits and milder side effects.
As a result, Merck’s pill is expected to have a lesser role against the pandemic than predicted just a few weeks ago. Its ability to head off severe COVID-19 is much smaller than initially announced and the drug label will warn of serious safety issues, including the potential for birth defects.
Both treatments will be free to patients in the U.S. after being purchased by the federal government.
The FDA authorized Merck’s drug for adults with a positive COVID-19 test, early symptoms and who face the highest risks of hospitalization, including older people and those with conditions like obesity and heart disease.
The agency said molnupiravir should be considered for patients “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.” It did not include that restriction for Paxlovid, which was authorized for patients 12 and older.
Molnupiravir, made by Merck and Ridgeback Biotherapeutics, also will carry a warning against use during pregnancy. Women of childbearing age should use birth control during treatment and for a few days after while men should use birth control for at least three months after their final dose, the FDA said. The federal agency also said molnupiravir should not be used in patients under age 18 because it may affect bone growth.
