New Delhi: European Medicines Agency (EMA) which is in charge of the evaluation and supervision of medicinal products for the European Union (EU) has approved the Pfizer COVID pill for emergency use in the member states.
"The medicine, which is not yet authorised in the 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," the EMA said in a statement, as quoted by news agency AFP.
It further added that "EMA issued this advice to support national authorities who may decide on possible early use of the medicine... for example in emergency use settings, in the light of rising rates of infection and deaths due to COVID-19 across the EU."
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The COVID treatment, dubbed Paxlovid, is a combination of a new molecule, PF-07321332, and HIV antiviral ritonavir, which are taken as separate tablets.
"Paxlovid should be administered as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms," the EMA stated, adding that the pills should then be taken for five more days.
As per the EU drug regulator, the most common side effects include a disturbance of the sense of taste, diarrhoea, and vomiting. The drug should not be used by pregnant women, and breastfeeding should be interrupted while it is being taken, it advised.
The watchdog also informed that it was launching a "rolling review" of the Pfizer pill at the same time which can lead to its eventual approval in a matter of months, reported AFP.
Based on early data in approximately 1,200 patients, Pfizer Inc reported last month that the pill was roughly 89 per cent effective in reducing hospitalisations or deaths when compared to placebo.
As per Pfizer Inc, recent lab data suggested its antiviral COVID-19 pill was effective against the fast-spreading Omicron variant of the Coronavirus. An additional 1,000 persons were included in the trials of which data was released on Tuesday.
The US pharmaceutical company also stated that the final analysis of its oral medicine showed near 90 per cent efficacy in preventing hospitalisations and deaths in high-risk patients infected with COVID-19, Reuters reported.
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No Deaths Among Those Who Received Pfizer Treatment During Trial
During the trial, nobody died after receiving the Pfizer treatment. However, 12 deaths were recorded among placebo recipients.
As per the treatment, the Pfizer pills are taken with antiviral ritonavir every 12 hours for five days beginning after the onset of symptoms.
Preliminary results from a second clinical study showed that the treatment decreased hospitalisations by 70 per cent in 600 standard-risk patients, the report by Reuters mentioned.
Pfizer had stated that it can ship 180,000 treatment courses this year and plans to produce at least 80 million more in 2022.