Pfizer Inc. said its Covid-19 pill reduced hospitalizations and deaths in high-risk patients by 89%, a result that has the potential to upend how the disease caused by the coronavirus is treated and alter the course of the pandemic. The shares surged.
The drugmaker said in a statement on Friday that it was no longer taking new patients in a clinical trial of the treatment “due to the overwhelming efficacy” and planned to submit the findings to U.S. regulatory authorities for emergency authorization as soon as possible.
The results mean there are now two promising candidates for treating Covid-19 patients early in the course of the disease. Last month, Merck & Co. and partner Ridgeback Biotherapeutics LP submitted their experimental pill to regulators after a study showed it slashed the risk of getting seriously ill or dying by half in patients with mild-to-moderate Covid-19.
Pfizer gained 13% in premarket U.S. trading, while Merck fell 9.3%. Some vaccine makers lost ground, with Moderna Inc. down 11% and Pfizer partner BioNTech SE slipping 9.4% in German trading.
A pill that could be taken at home at the first sign of symptoms is a crucial tool for taming the Covid-19 crisis globally, so long as it’s widely available. A Pfizer spokesperson said submissions to other regulatory agencies will occur shortly after the U.S. filing.
In Pfizer’s trial of 1,219 unvaccinated adults, five days of treatment with its drug dramatically reduced the rate of hospitalization when it was started within either three days or five days of symptom onset, the company said. The drug, Paxlovid, binds to an enzyme called a protease to stop the virus from replicating itself. Some drugs for HIV work in a similar way.
Overall, just 0.8% of people who started treatment within three days of getting sick ended up in the hospital and no one died, while 7% of people who got a placebo in that window were later hospitalized or died. Similar results were found when the drug was started within five days of symptom onset. The result, which hasn’t been published in a medical journal, was highly statistically significant, Pfizer said.
Acute Need
Current treatment options for Covid aren’t ideal. Monoclonal antibodies from companies like Regeneron Pharmaceuticals Inc. and Eli Lilly & Co. reduce hospitalizations, but the infusions are hard to manufacture and must be given in a medical office, adding to the strain on health systems.
Other medications like Gilead Sciences Inc.’s remdesivir are used to treat much sicker people who are already in the hospital. Low-cost steroid dexamethasone, while very effective, is usually only given to gravely ill patients.
The need for a pill is so acute that Merck has already agreed to allow generic drugmakers to apply for licenses to make its treatment for more than 100 low- and middle-income nations, before it has even been cleared in the U.S. The U.K.’s drug regulators became the first in the world to greenlight Merck’s drug Thursday after a swift review.