WASHINGTON (AP) – Pfizer Inc. said Friday that its experimental antiviral pill for COVID-19 cuts hospitalization and mortality among high-risk adults by nearly 90%, as the drugmaker previously reported. Joins the race for ease of use. Drug against coronavirus in US market.
All COVID-19 treatments currently used in the US require an IV or injection. Competitor Merck’s COVID-19 pill is already under review at the Food and Drug Administration after showing strong preliminary results, and on Thursday the United Kingdom became the first country to have a vaccine.
Pfizer said it would ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended halting the company’s study based on the strength of its results. Once Pfizer is implemented, the FDA could make a decision within weeks or months. If authorized, the company will sell the drug under the brand name Paxlovid.
Researchers around the world are racing to find a pill against COVID-19 that can be taken at home to ease symptoms, speed up recovery and reduce the crushing burden on hospitals and doctors.
Pfizer released the preliminary results of its study of 775 adults on Friday. Patients who received the company’s drug with another antiviral immediately after showing symptoms of COVID-19 had a combined rate of hospitalization or death after one month, compared with 89% of patients taking a dummy pill. was lacking. Less than 1% of patients taking the drug required hospitalization and none died. In the comparison group, 7% were hospitalized and seven deaths occurred.
“We were hoping we had something extraordinary, but it’s rare that you see great drugs come with almost 90% efficacy and 100% safety for death,” said Dr. Mikel Dolston, chief scientific officer at Pfizer. Said in an interview.
Study participants with mild to moderate COVID-19 were unvaccinated, and were considered to be at high risk for hospitalization due to health problems such as obesity, diabetes or heart disease. Treatment began within three to five days of initial symptoms, and lasted for five days. Patients who had previously received the drug showed slightly better outcomes, underscoring the need for rapid testing and treatment.
Pfizer reported few details on side effects but said the rate of problems was about the same between 20% of the groups.
An independent group of medical experts overseeing the trial recommended stopping this initial, standard procedure, when interim results show such a clear benefit. The data have not yet been published for external review, the usual procedure for examining new medical research.
Top US health officials have been insisting that vaccination remains the best way to prevent infection. But with millions of adults still uninfected – and many more globally – effective, easy-to-use treatments will be key to preventing future waves of infection.
The FDA held a public meeting later this month to review Merck’s pill, known as molnupiravir. The company reported in September that its drug cut hospitalizations and mortality rates by 50%. Experts caution against comparing preliminary results because of differences in studies.
Although Merck’s pill is ahead in the US regulatory process, Pfizer’s drug could benefit from a safety profile that is more familiar to regulators with fewer red flags. While pregnant women were excluded from the Merck trial because of the potential risk of birth defects, Pfizer’s drug had no similar restrictions. The Merck drug works by interfering with the genetic code of the coronavirus, a new approach to disrupting the virus.
Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme that the virus needs to multiply in the human body.
The drug was first identified during the 2003 SARS outbreak in Asia. Last year, the company’s researchers decided to revive the drug and study it for COVID-19, noting the similarities between the two coronaviruses.
The US has approved another antiviral drug, remdesivir, for COVID-19, and authorized three antibody therapies that help the immune system fight the virus. But they had to be given by IV or injection in hospitals or clinics, and limited supplies were affected by the eventual surge of the Delta version.
Shares of Pfizer rose more than 9% before Friday’s opening bell.
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.