EU drug agency gives advice on use of Pfizer COVID-19 pill
The Hague, Netherlands – The European Union drug regulator issued advice Thursday on the use of Pfizer’s experimental pill to treat COVID-19 to countries where authorities may want to use it before it is officially authorized amid surging infection rates.
The European Medicines Agency said the medicine, which is not yet authorized for use in the 27-nation EU, “can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.” It said the drug should be given as soon as possible after diagnosis of COVID-19 and within 5 days of the start of symptoms.
Pfizer said earlier this week that the pill, called Paxlovid, appears effective against the new omicron variant that is currently sweeping through the United Kingdom and has been detected in dozens more countries around the world.
Pfizer said this week that full results of its 2,250-person study confirmed the pill’s promising early results against the virus: The drug reduced combined hospitalizations and deaths by about 89% among high-risk adults when taken shortly after initial COVID-19 symptoms.
The EMA said in a statement it issued the advice “to support national authorities who may decide on possible early use of the medicine prior to marketing authorization, for example in emergency use settings, in the light of rising rates of infection and deaths due to COVID-19 across the EU.”
The EMA based its decision on a study of non-hospitalized, unvaccinated patients who had COVID-19 and at least one underlying condition that put them at risk of developing severe COVID-19 symptoms.
“These data showed that Paxlovid reduced the risk of hospitalisation and death when treatment started within 5 days of the start of symptoms,” the agency said.
It said the study showed about 1% of patients who took the Pfixer pill within five days of the start of symptoms were hospitalized within 28 days of starting treatment compared with 6.7% of patients who were given a placebo. It said none of the patients in the group who took the pill died compared with 10 patients in the placebo group.
Pfizer Chairman and Chief Executive Officer Albert Bourla welcomed the EMA advice.
“COVID-19 continues to take lives at an unprecedented pace globally and exacts a devastating toll on health care systems,” he said in a statement. “If authorized, PAXLOVID has the potential to help save lives and reduce hospitalizations. We look forward to working with the EMA and other regulatory agencies worldwide to bring this potential treatment to patients as quickly as possible.”