Pfizer's antiviral pill gets nod from EU regulator

NEW YORK • Pfizer's Covid-19 pill has received backing from the European Union's drug regulator, offering a tool to manage infections at home and ease the burden on hospitals.

The European Medicines Agency's (EMA) expert committee recommended granting conditional marketing authorisation for the antiviral, called Paxlovid, for adults with Covid-19 who do not require supplemental oxygen and are at risk of developing severe disease, said the regulator on Thursday.

The agency had already ruled last month that the treatment could be used by adults, in advance of formal approval.

The prospect of a pill that can be taken orally at home at the first sign of symptoms is sparking optimism about the course of the pandemic, especially amid evidence that the Omicron variant causes less severe disease.

Pfizer shares rose as much as 2.7 per cent in early US trading.

Paxlovid, which works by binding to an enzyme to stop the virus from replicating, reduced hospitalisation and death among high-risk patients by 89 per cent in a trial of 1,219 unvaccinated individuals.

Pfizer has since said that laboratory testing has shown the treatment is effective against the Omicron variant.

The European Commission will now "fast-track the decision-making process" on granting a conditional authorisation for the drug, said the EMA.

The UK regulator cleared Paxlovid at the end of last year, and the drug also has emergency-use authorisation in the United States.

The agency said in December that the treatment could be used by adults, in advance of formal approval.

The EMA is still reviewing Merck's Covid-19 pill, molnupiravir, which could provide another at-home treatment option for those infected with the virus.

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