Pfizer Asks FDA to Clear Covid Pill for High-Risk Patients

(Bloomberg) -- Pfizer Inc. asked U.S. regulators for emergency-use authorization 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% at 2:34 p.m. 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 & 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. 

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 hospitalizations and deaths in high-risk patients by 89% -- 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 U.K. Australia, New Zealand and South Korea.

Read More: Merck, Pfizer Covid Pills Could Massively Reduce Pandemic Deaths

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 U.S. has secured some supplies.

Authorization 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 & 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.  

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