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One Paxlovid tablet
Photo: Pfizer / dpa
The EU medicines agency Ema has given the green light for approval of the drug Paxlovid against Covid-19.
The drug from the US manufacturer Pfizer can prevent serious illness after a corona infection in adult patients, the Ema announced on Thursday in Amsterdam.
After approval, Paxlovid will be the first drug that patients can take orally at home.
The Covid pill is considered to be very effective, and it is said to reduce the risk of very serious illnesses by 89 percent, especially in people with previous illnesses.
Now the EU Commission still has to approve the approval, but that is considered a formality.
"The safety profile of Paxlovid was favorable and side effects were generally mild," the Ema experts noted.
"Based on laboratory studies, it is also expected to be active against omicron and other variants."
One million packs already ordered
It is still unclear when the drug will be available in pharmacies on prescription.
According to Federal Health Minister Karl Lauterbach (SPD), one million packs of Paxlovid have been ordered.
"The drug is particularly suitable for the treatment of unvaccinated high-risk patients," he had said.
According to the manufacturer, patients take three tablets twice a day for five days.
The active ingredient nirmatrelvir is intended to inhibit a Sars-CoV-2 protein and thereby stop the virus from multiplying.
Possible side effects include an impaired sense of taste, diarrhea, high blood pressure and muscle pain.
The drug could also affect the effects of other drugs, Ema warns.
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Ema's experts had been examining data from the manufacturer's studies for a long time and evaluating the benefits and risks.
The authority had already given the EU member states the green light for national emergency approval.
Shortly before Christmas, the US Food and Drug Administration (FDA) granted emergency use approval for Paxlovid.
The US manufacturer speaks of an "overwhelming effectiveness".
The drug could hit the virus at a "vulnerable point," said Daniel Kalanovic, medical director at Pfizer in Germany.
"The active substance blocks one of the most important enzymes that the corona virus needs in order to multiply." He hopes that the "turning point in the pandemic" can also be reached with this.
EU Health Commissioner Stella Kyriakides welcomed Ema's recommendation.
This drug could "make a real contribution to alleviating the consequences of Covid".
Drugs like Paxlovid are considered by experts to be a pillar of the fight against coronavirus.
However, compared to preventive vaccinations, they are significantly more expensive and often more complicated to use.
Before they were approved, they were tested on fewer people than the vaccines – hundreds of millions of which have also been administered worldwide for months and are being monitored at the same time.
The FDA had also stated that the drug was not a substitute for vaccination for the general public.
mar/dpa
