EU drug regulator EMA gives green light to Pfizer antiviral Covid-19 pill
Amsterdam · Two years after the start of the pandemic, a new treatment is available. Paxlovid is intended to prevent severe illness. It is the first oral drug that can be taken at home to treat people with Covid-19.
The EU medicines agency EMA has given the green light for the approval of the drug Paxlovid, which can be used to treat people who have Covid-19. The drug from the U.S. manufacturer Pfizer can prevent severe disease in adult patients with a Covid-19 infection, the EMA announced in Amsterdam.
Once approved, Paxlovid will be the first drug that patients can take orally at home. The pill is considered very effective, especially in people with pre-existing conditions. It is said to reduce the risk of very severe disease progression by 89 percent.
Now the EU Commission has to sign off on the approval, but that is considered a formality. "The safety profile of Paxlovid was favorable and side effects generally mild," EMA experts noted. "Based on laboratory studies, it is also expected to be effective against the Omicron variant and other variants.”
One million courses ordered
It is still unclear when the drug will be available by prescription at pharmacies. According to German Federal Health Minister Karl Lauterbach (SPD), one million courses of Paxlovid have been ordered. "The drug is particularly suitable for the treatment of unvaccinated high risk patients," he said. Including this new drug, there are now a total of seven drugs which have been approved in the EU for the treatment of Covid-19 patients.
According to the manufacturer, patients take three tablets twice a day for five days. The active ingredient, nirmatrelvir, is designed to inhibit a Sars CoV-2 protein, thereby stopping the virus from replicating. Possible side effects include impaired sense of taste, diarrhea, high blood pressure and muscle pain. However, the drug could interfere with the efficacy of other drugs, the EMA warns.
EMA experts had already been reviewing data from the manufacturer's studies for some time, assessing benefits and risks. And the drug regulator had also already given the green light to EU member states for a national emergency approval.
Hope that it will help “turn the tide of the pandemic”
The U.S. manufacturer speaks of "overwhelming efficacy." The drug can hit the virus at a "vulnerable spot," said Daniel Kalanovic, medical director at Pfizer in Germany. "The drug blocks one of the key enzymes that the coronavirus needs to replicate." He said he hopes that this can also be used to "turn the tide of the pandemic."
EU Health Commissioner Stella Kyriakides, welcomed the EMA's recommendation. This drug could make "a real contribution to alleviating the consequences of Covid," she said.
Orig. text: dpa
Translation: ck
