WASHINGTON (AP) – Pfizer Inc. said Friday its experimental antiviral pill for COVID-19 cut hospitalizations and deaths by nearly 90% as the drugmaker joins the race to bring the first easy-to-use coronavirus drug to the U.S. market.
Currently, all COVID-19 treatments used in the US require an IV or injection. Competitor Merck’s COVID-19 pill is already under review by the Food and Drug Administration after showing strong initial results, and on Thursday the UK was the first country to agree.
Pfizer said it will ask the FDA and international regulators to approve the pill as soon as possible after independent experts recommended that the company’s study be halted based on the strength of the results. Once Pfizer applies, the FDA can make a decision within weeks or months.
Researchers worldwide have raced to find a pill against COVID-19 that can be taken at home to relieve symptoms, speed recovery and reduce the crushing burden on hospitals and doctors.
Pfizer released preliminary results of its survey of 775 adults on Friday. Patients taking the company’s drug along with another antiviral had an 89% reduction in the combined number of hospitalizations or deaths after one month, compared with patients taking a dummy pill. Less than 1% of patients taking the drug had to be hospitalized and none died. In the comparison group, 7% were hospitalized and there were seven deaths.
“We were hoping we’d have something out of the ordinary, but it’s rare to see great drugs come out with nearly 90% efficacy and 100% protection against death,” said Dr. Mikael Dolsten, Pfizer’s Chief Scientific Officer, in an interview.
Study participants were unvaccinated, with mild to moderate COVID-19, and were considered to be at high risk of hospitalization due to health conditions such as obesity, diabetes or heart disease. Treatment started within three to five days of the first symptoms and lasted for five days.
Pfizer reported few details on side effects, but said the problems were similar between the groups at about 20%.
An independent group of medical experts following the study recommended stopping it early, a standard procedure when interim results show such a clear benefit. The data has not yet been published for external review, the normal process for vetting new medical research.
US health officials continue to stress that vaccination will remain the best way to protect against infection. But with tens of millions of adults still unvaccinated — and many more worldwide — effective, easy-to-use treatments will be critical to curbing future waves of infections.
The FDA has called a public meeting later this month to review Merck’s pill known as molnupiravir. The company reported in September that its drug reduced hospitalizations and deaths by 50%. Experts caution against comparing preliminary results because of differences in studies.
While Merck’s Pill is more advanced in the US regulatory process, Pfizer’s drug could benefit from a safety profile better known to regulators with fewer red flags. While pregnant women were excluded from the Merck study due to a potential risk of birth defects, Pfizer’s drug had no similar limitations. The Merck drug works by interfering with the coronavirus’ genetic code, a novel approach to disrupting the virus.
Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors that have revolutionized the treatment of HIV and hepatitis C. The drugs block an important enzyme that viruses need to get into the body. human body to multiply.
The drug, which has not yet been named, was first identified during the SARS outbreak from Asia in 2003. Last year, company researchers decided to revive and study the drug for COVID-19, given the similarities between the drugs. two coronaviruses.
The US has approved another antiviral drug for COVID-19, remdesivir, and approved three antibody therapies that help the immune system fight the virus. But they must be administered by IV or injection in hospitals or clinics, and limited supplies were strained by the latest wave of the delta variant.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.