FDA advisers recommend authorising first anti-viral pill to treat Covid

An advisory panel for the Food and Drug Administration voted 13-10 to endorse the first antiviral pill to treat adults at high risk of severe illness from Covid-19, among the first oral antiviral drugs that could serve as a key component of warding off the public health crisis, as the US braces for the emergence of the omicron variant.

The drug developed by Merck and Ridgeback Biotherapeutics – molnupiravir– is a five-day pill regimen to be used at home within five days of the onset of symptoms, potentially relieving overstressed hospitals.

Last week, Merck announced that the drug reduced the risk of hospitalisation or death in patients with mild to moderate Covid-19 symptoms by roughly 30 per cent.

The FDA is not bound by the split vote on 30 November, though the agency does typically support its external advisers’ recommendations.

Merck has pledged to produce enough pills treat 10m patients by the end of the year, and the US government has ordered enough medicine to treat more than 3m people.

“With the continued spread of the virus and the emergence of variants, additional treatments for Covid-19 are urgently needed,” said Dr Dean Y Li, executive vice president and president of Merck Research Laboratories. “That is why we are moving with speed and rigor to pursue authorizations and to accelerate broad global access to this investigational medicine.”

The advisory panel’s recommendation comes as US health officials expand their research into the latest variant, which has not yet been detected in the country.

Omicron carries a worryingly high number of mutations of a “spike” protein that attaches to human cells, prompting some fears among health officials that the variant could be more transmissible and test the efficacy of current vaccines.

The pills do not target the spike protein; they weaken two proteins involved with the ability of the virus to replicate. Omicron reportedly carries only one mutation in each of those proteins. Merck has argued that its drug is likely to work against new variants, and the company is working to determine how well it stands up against omicron.

Another oral pill regimen, one that is being developed by Pfizer and could be more effective than the Merck regimen, is also facing FDA review.

Dr Rochelle Walensky, director of the Centers for Disease Control and Prevention, told reporters on Tuesday that the agency is “actively looking” for the new variant’s presence in the US; the delta variant remains the dominant variant in the US, accounting for roughly 99 per cent of new cases.

On 29 November, President Joe Biden to sought to project calm following the emergence of omicron, telling Americans in an address from the White House on Monday that the variant is a “cause for concern, not a cause for panic.”

“We’re going to fight and beat this new variant as well,” he said. “The best protection ... is getting fully vaccinated, and getting a booster shot,” he said.

White House medical adviser Dr Anthony Fauci said it would likely take up to two weeks to know more about the variant, including its vaccine response, transmissibility and health impacts.

“We should not be freaking out,” he told CBS. “We should be doing the things that we know work when you’re dealing with a pandemic virus. It’s not the time to panic.”

He added: “We should be concerned, and our concern should spur us to do the things that we know work.”