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.”
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