EU drug regulator green-lights Pfizer COVID-19 pill

The Committee recommended authorising Paxlovid for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.

Paxlovid is the first antiviral medicine to be given by mouth that is recommended in the EU for treating COVID-19.

How does Paxlovid work?
It contains two active substances, PF-07321332 and ritonavir, in two different tablets. PF-07321332 works by reducing the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body while ritonavir prolongs the action of PF-07321332 enabling it to remain longer in the body at levels that affect the multiplication of the virus.

Main findings

In reaching its conclusion, the EMA's human medicines committee (CHMP) evaluated data from a study involving patients with COVID-19 showing that

treatment with Paxlovid significantly reduced hospitalisations or deaths in patients who have at least one underlying condition putting them at risk of severe COVID-19.

The analysis was done in patients who received Paxlovid or placebo (dummy treatment) within 5 days after COVID-19 symptoms began and who did not receive, nor were expected to receive, treatment with antibodies. Over the month following treatment, 0.8% (8 out of 1,039) of the patients receiving Paxlovid were hospitalised for longer than 24 hours, compared with 6.3% (66 out of 1,046) of those who received placebo. There were no deaths in the Paxlovid group and 9 deaths in the placebo group.

The majority of patients in the study were infected with the Delta variant. Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants.

Reuters underlined that in the trial Paxlovid was only tested on unvaccinated individuals, raising questions on its potential use in high-risk patients who did get inoculated. EMA did not limit its endorsement to the non-vaccinated.

The safety profile of Paxlovid was favourable and side effects were generally mild. However, ritonavir is known to affect the action of many other medicines, and warnings and advice have been included in Paxlovid’s product information.

The United States in December authorised Paxlovid and Merck's similar drug molnupiravir. Merck's pill is also under review in the EU, but is taking longer to approve because the company revised its trial data in November, saying the drug was significantly less effective than previously thought.

The endorsement by the EMA for a conditional approval, if followed as usual by the European Commission, allows EU member states to deploy the drug after the regulator gave guidance for its emergency use late last year.

Italy, Germany and Belgium are among a handful of EU countries that have bought the drug, branded as Paxlovid.

EU health commissioner Stella Kyriakides highlighted that Paxlovid is the first oral antiviral for home use in the bloc's portfolio, "and has the potential to make a real difference for persons at high risk of progression to severe COVID."

"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," Pfizer Chief Executive Albert Bourla said in a statement.

Germany ordered 1 million courses late in December. Health Minister Karl Lauterbach said on Jan. 2 he expected the country's drug regulator to give a national emergency go-ahead before the end of the month and that rollout would start then.

Italy will receive 200,000 courses in February and has the option to buy an additional 400,000.