The first pills to treat Covid-19 are expected to be approved by the US federal regulators this week.
The FDA will give Pfizer and Merck the go-ahead to launch their new oral treatments as soon as Wednesday, according to sources quoted by Bloomberg News.
The approval of Paxlovid and molnupiravir would come at a time when we absolutely need it, said Eric Topol, director of the Scripps Research.
It is a sign of light in a tunnel. It will not be realized unless we pull out all the stops to quickly get it made and distributed at mass scale.
The late-year timing of the announcement reflected the urgent need for the medicines, Topol said.
In clinical trials, Paxlovid was shown to be effective in preventing hospitalization and death in high-risk patients.
Albert Bourla, the chief executive of Pfizer, said in a statement that his company's product could be a critical tool to help quell the pandemic.
The road towards the market has been bumpy. The UK became the first country in the world to approve the twice-daily pill for elderly and vulnerable people.
The US regulators sought independent analysis on the risks of birth defects and other problems in pregnant women, even though it was less effective than Paxlovid.
An FDA advisory panel has a recommendation. Emergency use authorization this week would show that concerns have been reduced or eliminated.
Men and women were told to use contraception or not have sex in the study. The pill did not cause damage to the DNA, according to testing by the company.
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molnupiravir reduced the risk of hospitalisation and death by 30%.
The US government has ordered about 10 million courses of Pfizer and 3 million courses of Merck. The medicines are not expected to be widely available.
Topol wrote in the Guardian that pill pack production must be quickly scaled for wide accessibility and use throughout the world, whether that involves the Defense Production Act in the United States or other bold measures.
If we had an unlimited supply of these pills, it would have a huge impact on preventing illness, preserving our healthcare workforce, staving off spread and eliminating the need for school closings.
