PFIZER’S COVID-19 PILL PAXLOVID CAN BE USED BY EU STATES: REGULATOR

Fri 17 December 2021:

The European Medicines Agency (EMA) has issued advice on the emergency use of Pfizer’s Covid-19 pill called Paxlovid. The European Union (EU) drug regulator on Thursday said the medicine, which is not yet authorized 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 medicine, which is not yet authorized 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,” read a statement by the European Medicines Agency (EMA).

Paxlovid should be administered as soon as possible after diagnosis of Covid-19 and within five days of the start of symptoms, it added.

The EMA said its advice was for “national authorities who may decide on the 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.”

A study in “non-hospitalized, unvaccinated patients who had symptomatic disease and at least one underlying condition … showed that Paxlovid reduced the risk of hospitalization and death when treatment started within 5 days of the start of symptoms,” read the statement.

“About 1% of patients (6 out of 607) who took Paxlovid within five days of the start of symptoms were hospitalized within 28 days of starting treatment compared with 6.7% of patients (41 out of 612) given placebo (a dummy treatment); none of the patients in the Paxlovid group died compared with 10 patients in the placebo group,” the EMA said.

The most common side effects reported during treatment and up to 34 days after the last dose of Paxlovid were dysgeusia (taste disturbance), diarrhea and vomiting, the agency added.

EMA said it issued this 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, Xinhua news agency reported.

Paxlovid is an oral antiviral medicine that reduces the ability of SARS-CoV-2 (the virus that causes Covid-19) to multiply in the body.

SOURCE: INDEPENDENT PRESS AND NEWS AGENCIES

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