US health regulators have authorised a second pill to treat COVID-19, providing another easy-to-use medication to battle the rising tide of Omicron infections.
The Food and Drug Administration (FDA) authorisation 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, due to its superior benefits and milder side effects.
As a result, Merck's pill is expected to play a smaller role against the pandemic than predicted just a few weeks ago.
Its ability to head off severe COVID-19 is more limited than initially announced and the drug label will warn of serious safety issues, including the potential for birth defects.
The FDA authorised Merck's drug for adults with early symptoms of COVID-19 who face the highest risks of hospitalisation, including older people and those with conditions like obesity and heart disease.
Molnupiravir 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 hospitalisation and death by nearly 90 per cent among high-risk patients, compared with 30 per cent for Merck's.
Molnupiravir vs Paxlovid
Some experts question whether there will be much of a role for the Merck drug in the US.
"To the extent that there's an ample supply of Pfizer's pill, I think [the Merck drug] won't be used," said Gregory Poland of the Mayo Clinic.
"There would be no reason, given it has less efficacy and a higher risk of side effects."
For now, the FDA decision provides another potential option against the virus that has killed more than 800,000 Americans, even as health officials brace for record-setting cases, hospitalisations and deaths driven by the Omicron variant.
Antiviral pills, including Merck's, are expected to be effective against Omicron because they don't target the spike protein where most of the variant's worrisome mutations reside.
The FDA based its decision on results showing nearly 7 per cent of patients taking the drug ended up in the hospital and one died at the end of 30 days.
That compared with 10 per cent of patients hospitalised who were taking the placebo, and nine deaths.
Federal officials have agreed to purchase enough of the drug to treat 3.1 million people.
Source: ABC news
BDST: 1158 HRS, DEC 25, 2021
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