US adds Merck pill as 2nd easy-to-use drug against COVID-19
WASHINGTON (AP) — 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 authorization of Merck's molnupiravir comes one day after the agency cleared a competing drug from Pfizer. That pill, Paxlovid, is likely to become the first-choice treatment against the virus, thanks to its superior benefits and milder side effects.
As a result, Merck's pill is expected to have a smaller 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.
The Food and Drug Administration authorized Merck’s drug for adults with early symptoms of COVID-19 who face the highest risks of hospitalization, including older people and those with conditions like obesity and heart disease. The U.K. first authorized the pill in early November.
Known as molnupiravir, the Merck drug 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 restrictions were expected after an FDA advisory panel only narrowly endorsed the drug last month, warning that its use would have to be strictly tailored to patients who can benefit the most.
The Pfizer pill works differently and doesn't carry the same risks. Additionally, Pfizer's drug was roughly three times more effective in testing, reducing hospitalization and death by nearly 90% among high-risk patients, compared with 30% for Merck's.