THE HAGUE: The EU’s drug watchdog approved Pfizer’s coronavirus pill on Thursday, making it the first oral antiviral treatment for the disease to be authorised in Europe.
Studies showed the drug called Paxlovid reduces hospitalisation and death in patients at risk of severe Covid, and may also be effective against the Omicron variant.
Pills are seen as a potentially huge step in ending the pandemic as they can be taken at home, rather than in hospital.
“Paxlovid is the first antiviral medicine to be given by mouth that is recommended in the EU for treating Covid-19,” the European Medicines Agency (EMA) said in a statement.
The United States, Canada and Israel are among a handful of countries to have already given the green light to the Pfizer treatment.
The European Commission must now formally authorise the drug but that is a rubber-stamp procedure that usually takes hours or days.
“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,” EU Health Commissioner Stella Kyriakides said in a statement. “We have also seen the promising evidence regarding Paxlovid’s effectiveness against Omicron and other variants.”
The Pfizer treatment is a combination of a new molecule, PF-07321332, and HIV antiviral ritonavir, that are taken as separate tablets.
The EMA said it “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”.
Published in Dawn, January 28th, 2022