European drugs watchdog recommends conditional marketing authorization for Paxlovid

NETHERLANDS – The European Union’s drug regulator has approved Pfizer Inc’s antiviral COVID-19 pill for treating adults at risk of severe illness, as the region scrambles to beef up its arsenal against the Omicron variant.

The European Medicines Agency’s (EMA) approval for conditional approval, if followed by the European Commission as usual, allows EU member states to deploy the drug after the regulator issued guidance for its emergency use late last year.

Paxlovid and Merck’s similar drug molnupiravir were approved in the United States in December.

Stella Kyriakides, the EU’s health commissioner, said the bloc was now making good progress in developing treatments, which she described as a “second line of defense” after vaccines.

“Paxlovid is the first oral antiviral for home use in our portfolio, and has the potential to make a real difference for persons at high risk of progression to severe COVID,” she said.

Merck’s pill is also being considered in the EU, but it will take longer to get approved because the company revised its trial data in November, claiming that the drug was significantly less effective than previously thought.

These oral drugs, particularly those manufactured by Pfizer, are viewed as promising new treatment options that can be taken at home at the onset of COVID-19 symptoms, thereby reducing hospitalizations and deaths.

Commenting on this new development, Pfizer Chief Executive Albert Bourla said, “We are proud to have a strong manufacturing footprint in Europe, which will help support the production of up to 120 million courses of Paxlovid globally.”

According to data from the company’s clinical trial, Paxlovid, a two-drug antiviral regimen, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness. New laboratory data shows that the drug is still effective against the Omicron variant.

However, it was only tested on unvaccinated individuals in the trial, raising concerns about its potential use in high-risk patients who were inoculated. The EMA’s approval was not limited to the unvaccinated.

More than ten countries, including the United States and the United Kingdom, have approved or authorized the oral antiviral treatment for emergency use. Italy, Germany, and Belgium are among the European Union countries that have purchased the drug.

Late in December, Germany ordered one million courses. On January 2, Health Minister Karl Lauterbach stated that he expected the country’s drug regulator to approve a national emergency declaration before the end of the month, and that the rollout would begin then.

Italy will receive 200,000 courses in February and will have the option of purchasing an additional 400,000.

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