Pfizer asks US regulators for emergency-use authorisation of Covid-19 pill

Pfizer has 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’s key to coronavirus replication and would be the first of its kind if cleared, Pfizer said Tuesday in a statement. Unlike most other Covid treatments, it could be prescribed for home use. The shares rose 0.5 per cent at 2.34pm in New York.

Pfizer said it will invest as much as $1 billion to support the pill’s manufacturing and distribution. The Biden administration plans to buy enough of the pills to treat 10 million patients, according to people familiar with the matter, who asked not to be named as the details aren’t 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 and Co. and its partner Ridgeback Biotherapeutics LP 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.

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Some patients are at increased risk of worsening symptoms because of underlying conditions such as diabetes, obesity or weakened immune systems. Pfizer said earlier this month that Paxlovid cut hospitalisations 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 authorized, underscores the critical role that oral antiviral therapies could play in the battle against Covid-19,” Pfizer Chief Executive Officer Albert Bourla said in the statement.

Bourla said the company is working quickly with regulators around the world to get the treatment into the hands of patients. Pfizer has launched rolling submissions in other countries, including the UK Australia, New Zealand and South Korea.

Earlier Tuesday, Pfizer said it signed an agreement with the United Nations-backed Medicines Patent Pool to license its experimental pill to generic companies that can supply it low- and middle-income countries, if it’s authorized. 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 Inc. and Eli Lilly and Co., and other drumakers. However, the costly infusions must be given in a medical facility, making it difficult for patients to get them early enough to be helpful. – Bloomberg