Pfizer asks US FDA to clear Covid-19 pill for high-risk patients

Company also working with UN agency to license pill for distribution to low-income countries

Pfizer's experimental Covid-19 antiviral pills are made inside a laboratory in Freiburg, Germany. Pfizer/AFP
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Pfizer asked US regulators for emergency use authorisation of its Covid-19 pill that could play a critical role in further protecting high-risk patients from the disease’s worst effects.

The drug, Paxlovid, blocks a crucial enzyme that is key to coronavirus replication and would be the first to be cleared, Pfizer said on Tuesday. Unlike most other Covid treatments, it could be prescribed for home use.

The company said it will invest as much as $1 billion to support the pill’s manufacturing and distribution.

The administration of US President Joe Biden plans to buy enough of the pills to treat 10 million patients, said people familiar with the matter, who asked not to be named as the details are not public.

Doctors have been calling for more and better Covid therapies, and Pfizer’s is the second oral Covid antiviral to go before the Food and Drug Administration.

Last month, Merck submitted data from its drug molnupiravir to the agency after a study showed it lowered the risk of serious illness or death by half in patients with mild to moderate disease.

Some patients are at increased risk of worsening symptoms because of underlying conditions such as diabetes, obesity or weakened immune systems.

Pfizer said this month that Paxlovid cut hospital admissions and deaths in high-risk patients by 89 per cent — results so promising that the drugmaker decided to stop testing the drug.

“The overwhelming efficacy achieved in our recent clinical study of Paxlovid and its potential to help save lives and keep people out of the hospital if authorised, underscores the critical role that oral antiviral therapies could play in the battle against Covid-19,” Pfizer chief executive Albert Bourla said.

Mr Bourla said the company is working quickly with regulators around the world. Pfizer has launched rolling submissions in other countries, including the UK, Australia, New Zealand and South Korea.

Earlier Tuesday, Pfizer said it had signed an agreement with the UN-backed Medicines Patent Pool to license its experimental pill to generic companies that can supply it to low- and middle-income countries, if it is authorised.

Merck has made similar arrangements to promote access to its pill and the US has secured some supplies.

Authorisation of the treatments will help expand options available to doctors. For those in the early stages of disease, they can prescribe monoclonal antibodies from Regeneron Pharmaceuticals and Eli Lilly as well as other drugmakers.

However, the costly infusions must be given in a medical facility, making it difficult for patients to take them early enough to be helpful.

Updated: November 16, 2021, 9:00 PM