The US Food and Drug Administration is poised to authorise two pills developed by Pfizer and Merck for the treatment of Covid as early as Wednesday this week.
Continuing a trend for rapid drugs innovation in the fight against Covid this year, the US watchdog is set to announce the authorisation of the new pills this week, Bloomberg first reported, citing people familiar with the matter.
The US follows the UK, which became the first country in the world to approve a potentially game-changing Covid antiviral pill at the beginning of last month.
Britian approved the first molnupiravir Covid antiviral pill that was jointly developed by US drug companies Merck & Co Inc and Ridgeback Biotherapeutics in November, and was due to begin administering it in a drug trial shortly after.
The UK regulator, the MHRA, said the tablet had been authorised for use in people who have mild to moderate Covid and at least one risk factor for developing severe illness such as obesity, old age, diabetes or heart disease.
Separately, Merck said it was expecting to produce 10 million courses of the treatment by the end of this year, with at least 20 million courses set to be manufactured in 2022.
Molnupiravir, developed by the US drug companies Merck, Sharp and Dohme (MSD) and Ridgeback Biotherapeutics, is the first oral antiviral medication for Covid which can be taken as a pill rather than injected or given intravenously.
It targets an enzyme that the virus uses to make copies of itself, introducing errors into its genetic code. That should prevent it from multiplying, so keeping virus levels low in the body and reducing the severity of the disease.
Meanwhile, Pfizer’s pill, which is the second to be developed so far, was found to reduce the risk of hospitalisation and death by 89 per in clinical trials last month.
Its latest round of trials showed that just 0.8 per cent of patients who received PAXLOVID were hospitalised and none died, compared to seven per cent of patients given the placebo.
The US government has reportedly ordered 10 million courses of the Pfizer pill and around 3 million courses of Merck’s, but they are far off being commonly available.