FDA expected to approve Covid treatment pills within days – The Guardian

US federal regulators are expected to approve the first pills to treat Covid-19 as early as this week, it was reported on Tuesday.

According to sources quoted by Bloomberg News, the Food and Drug Administration (FDA) will give the go-ahead for Pfizer and Merck to launch groundbreaking oral treatments perhaps as soon as Wednesday.

Amid a surge in cases caused by the Omicron virus variant, the approval of the Paxlovid (Pfizer) and molnupiravir (Merck) pills would come at a time “when we absolutely need it”, said Eric Topol, director of the Scripps Research Translational Institute, writing in the Guardian on Tuesday.

“It’s a sign of light in a very long tunnel. But its extraordinary promise will not get realized unless we pull out all the stops to quickly get it made and distributed at mass scale.”

Topol told Bloomberg the unusual late-year timing of the announcement reflected the urgency of the need for the medicines.

Paxlovid performed well in clinical trials, showing almost 90% efficacy in preventing hospitalization and death in high-risk patients.

Pfizer’s chief executive, Albert Bourla, said in a statement his company’s product could be “a critical tool to help quell the pandemic”.

Molnupiravir has had a bumpy road towards the market. Last month the UK became the first in the world to approve the twice-daily pill, which is targeted at the elderly and those most vulnerable to severe disease.

But cautious US regulators, while accepting its reduced efficacy compared with Paxlovid, sought independent analysis on the risks of birth defects and other problems in pregnant women.

An FDA advisory panel has recommended approval. Emergency use authorization this week would indicate that such concerns were reduced or eliminated.

Pregnant women were excluded from Merck’s study, and male and female subjects were instructed to use contraception or abstain from sex. Merck said testing on animals showed the pill did “not cause mutations or damage to DNA”.

The studies revealed that molnupiravir reduced the combined risk of hospitalisation and death by 30%.

The US government has ordered 10m courses of the Pfizer pill and about 3m from Merck, Bloomberg said. But the medicines are not expected to immediately be widely available.

“We must find a way to rapidly scale pill pack production for wide accessibility and use throughout the world, whether that involves enacting the Defense Production Act in the United States or other bold measures,” Topol wrote in the Guardian.

“If we had an unlimited supply of these pills, it could have an extraordinary impact on preventing illness, preserving our healthcare workforce, staving off spread, eliminating the need for lockdowns and school closings.”