New Delhi: The European Medicines Agency (EMA) which is in charge of the evaluation and supervision of medicines for the European Union (EU) has approved the Pfizer COVID pill for emergency use in member countries.
“The drug, which is not yet approved in the EU, can be used to treat adults with COVID-19 who do not need supplemental oxygen and who are at increased risk of progressing to disease serious, “the EMA said) in a statement, as reported by the AFP news agency reported.
He further added that “the EMA has issued this opinion to support national authorities who may decide on a possible early use of the medicine … EU.”
The treatment, called Paxlovid, is a combination of a new molecule, PF-07321332, and the anti-HIV antiviral ritonavir, which are taken as separate tablets.
“Paxlovid should be administered as soon as possible after a diagnosis of COVID-19 and within five days of the onset of symptoms,” the EMA said, adding that the pills should then be taken for an additional five days.
According to the EU medicines regulator, the most common side effects include disturbed sense of taste, diarrhea and vomiting. The drug should not be used by pregnant women and breast-feeding should be discontinued while it is being taken, he advised.
The watchdog also informed that it was simultaneously launching a “continuous review” of the Pfizer pill which led to its final approval within a few months, AFP reported.
Based on initial data from about 1,200 patients, Pfizer Inc reported last month that the pill was about 89% effective in reducing hospitalizations or deaths compared to placebo.
According to Pfizer Inc, recent lab data suggested that its COVID-19 antiviral pill was effective against the rapidly spreading Omicron variant of the coronavirus. A thousand more people were included in the trials, the data of which were released on Tuesday.
The U.S. company also said that the final analysis of its oral drug showed nearly 90% effectiveness in preventing hospitalizations and death in high-risk patients infected with COVID-19, Reuters reported.
No one died after receiving Pfizer treatment during trial
During the trial, no one died after receiving the Pfizer treatment. However, 12 deaths were recorded among the placebo recipients.
Depending on the treatment, Pfizer pills are taken with antiviral ritonavir every 12 hours for five days from the onset of symptoms. The treatment will be sold as Paxlovid after authorization.
Preliminary results from a second clinical study showed that the treatment reduced hospitalizations by 70% in 600 standard-risk patients, according to the Reuters report.
Pfizer has said it can ship 180,000 processing courses this year and plans to produce at least 80 million more by 2022.
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