- 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.
- It said the study showed about 1% of patients who took the Pfizer 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.
- Pfizer Chairman and Chief Executive Officer Albert Bourla welcomed the EMA advice.
The European Union’s medicines regulator provided guidance on Thursday to nations where authorities may seek to use Pfizer’s experimental COVID-19 treatment before it is formally approved, citing rising infection rates as a reason as reported by AP News.
New omicron version
The drug, which has not yet been approved for use in the EU’s 27 member states, “may be used to treat people with COVID-19 who do not require supplementary oxygen and are at elevated risk of advancing to severe disease,” according to the European Medicines Agency. It was recommended that the medicine be given as soon as feasible after a COVID-19 diagnosis and within 5 days of the onset of symptoms.
Pfizer announced earlier this week that the Paxlovid pill appears to be effective against the new omicron version that is currently sweeping the United Kingdom and has been found in dozens of other nations.
European Medicines Agency
The entire results of Pfizer’s 2,250-person research were released this week, confirming the pill’s encouraging early effects against the virus: When given soon after the onset of COVID-19 symptoms, the medicine reduced hospitalizations and fatalities by roughly 89% in high-risk patients.
The EMA issued the guidance “to assist national authorities who may decide on a possible early use of the drug prior to marketing authorization, for example in emergency usage settings, in view of increased incidence of infection and deaths due to COVID-19 across the EU,” according to the statement.
The European Medicines Agency (EMA) made its judgement based on a trial of non-hospitalized, unvaccinated patients with COVID-19 and at least one underlying illness that put them at risk of developing severe COVID-19 symptoms.
Wreaking havoc
“These findings revealed that starting Paxlovid medication within 5 days of the onset of symptoms lowered the chance of hospitalisation and mortality,” the agency said.
According to the study, about 1% of patients who took the Pfizer pill within five days of the onset of symptoms were admitted to the hospital within 28 days after starting treatment, compared to 6.7% of patients who received a placebo. According to the study, none of the patients in the pill group died, whereas ten patients in the placebo group died.
Albert Bourla, Chairman and Chief Executive Officer of Pfizer, was pleased with the EMA’s advice.
“COVID-19 continues to claim lives at an alarming rate across the globe, wreaking havoc on healthcare systems,” he added in a statement. “If PAXLOVID is approved, it has the potential to save lives and decrease hospitalizations. We look forward to collaborating with the EMA and other regulatory bodies across the world to get this potentially life-saving medicine to patients as soon as possible.”
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Source: AP News
