Paxlovid: Corona drug is here – the four most important pieces of information
Created: 03/03/2022Updated: 03/03/2022 18:53
By: Dominik Jahn
Paxlovid has “conditional marketing authorisation” for Europe.
The corona drug has not only provided positive data in studies.
Since the end of January 2022, Paxlovid has received “conditional marketing authorisation” from the European Medicines Agency (EMA).
After there were initially problems with delivery to Germany, the corona drug from manufacturer Pfizer has been available in Germany since February 23.
In addition to positive studies and a comparison with the preparation Molnupiravir from Merck & Co., critical voices about Paxlovid had recently been reported.
There was always talk of possible interactions with other medications.
Experts have even created a "red" list.
Paxlovid: First corona drug for the home
According to doctors, Paxlovid is the first corona drug for home use.
The preparation from Pfizer is taken in tablet form and is used to prevent severe courses.
echo24.de reports on this.
Conditional Authorization (CMA)
According to EMA's official statement, conditional authorization (CMA) is used as an accelerated authorization process to speed up the approval of medicines in public health emergencies in the EU.
CMAs allow for the approval of medicines that address an unmet medical need based on less complete data than would normally be required.
This occurs when the benefit of having a medicine readily available to patients outweighs the risk of not having all the data yet.
Especially since Paxlovid can also be taken at home, it is important to know some crucial information about the US manufacturer's corona pill.
Use and effect of Paxlovid
As
echo24.de has
already reported in earlier articles, Paxlovid is a combination therapy. It involves two crucial oral antiviral agents
.
The Pharmazeutische Zeitung, among others, wrote about the substances used:
“It is the new substance PF-07321332 developed by Pfizer, which is now called Nirmatrelvir and which inhibits the viral protease 3CL, which is important for the replication of SARS-CoV-2, and on the other hand the well-known ritonavir, which acts as a booster by slowing down the hepatic breakdown of nirmatrelvir via CYP3A4”
.
According to the manufacturer and numerous experts, taking Paxlovid must begin no later than five days after the onset of symptoms – and then for five days.
The corona drug is by no means a miracle cure.
A few days ago, the German Society for General and Family Medicine (DEGAM) told the
German Press Agency (dpa)
: "Paxlovid is not the way to overcome the pandemic, but the vaccination." Paxlovid is therefore rather an
"emergency nail"
.
Paxlovid: For whom does the corona drug make sense at all
In the dpa report, DEGAM also made it clear that its use requires
“extreme caution and good patient education and monitoring”
.
The area of application of Paxlovid is also limited.
Experts consider an application
"for the unvaccinated over 65 years of age who have not yet recovered"
to be useful.
Paxlovid is on the market.
Nevertheless, there are a few things to consider with the corona drug.
© Fabian Sommer |
dpa
Various studies have shown that Pfizer's preparation is considered to be very suitable for patients who are not vaccinated and have at least one risk factor.
Stefan Kluge, intensive care physician and expert from the German Society for Pneumology and Respiratory Medicine (DGP), explained to the dpa: "Based on previous data, it is not a drug for, for example, slim, athletic 20-year-olds or 60-year-olds with a booster who receive a positive test result .”
So far, there is no reliable data on use in vaccinated people in general.
And there is still no proof of effectiveness against the omicron variant of Corona.
The data for approval by the EMA predates Omicron.
However, the researchers assume protection against this variant.
On the other hand, molnupiravir has already delivered an omicron study.
Paxlovid available in pharmacies – this is how patients get the corona drug
As soon as it became clear that deliveries to Germany should start in February, there were first indications for patients how they could get Paxlovid.
As the
dpa
reports, Professor Kluge from the University Hospital Hamburg-Eppendorf also pointed out the problem of timely treatment in this regard.
Many patients could not go to the doctor immediately.
In addition, it would then take some time before the test result was available.
The Federal Union of German Associations of Pharmacists stipulates that, as an exception, doctors will send prescriptions directly to pharmacies, which will then order the drug from wholesalers and
deliver it to patients by
courier “with as little contact as possible” .
Pharmacies are not allowed to stock Paxlovid.
Pfizer with Paxlovid in the fight against Corona the winner in the billion dollar business
For the US pharmaceutical company Pfizer, Paxlovid is another top-selling drug in the fight against Corona.
The manufacturer already achieved good results with the vaccine Biontech at the beginning of the vaccination campaign.
The company is considered the big winner of the pandemic in the billion-euro business of pharmaceutical manufacturers.
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