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A limited number of doses of the antibody drug Regeneron have been ordered for use in Norwegian hospitals.
This is confirmed by the Norwegian Health Directorate.
– We have ordered the number of doses recommended by professional communities. How these drugs are used is continually decided in professional communities, says emergency director Steinar Olsen.
The Norwegian Health Directorate does not wish to comment on the number of doses ordered or the price.
Many will recognize Regeneron as the “cocktail of antibodies” former US President Donald Trump received when he was hospitalized with coronavirus in October last year. After this, there has been a lot of new data indicating that the drug provides protection.
According to sources from the New York Times, the former president’s health condition was much worse than what was publicly reported when he entered. He must have been so ill that respiratory treatment was considered. After being discharged, he vigorously bragged about the then experimental drug, which was one of several drugs he was treated with.
Expensive medicine
On Friday, the European Medicines Agency (EMA) decided to introduce an exemption provision for the use of the antibody drug Regeneron. The decision means that they provide general guidance on the fact that they believe the drug can be used, although it has not yet been approved in Europe.
Then it is up to each individual country to decide if they want to purchase it and therefore Norway has decided to do so.
This type of antibody drug works much like vaccines. Antibodies are injected that can fight the virus, but unlike vaccines, they work immediately and the effect also lasts for a shorter time.
Although the Norwegian Health Directorate will not say how much Norway has paid for how many doses, it can be assumed that the price is high: Germany became the first EU country to buy the drug in January, and the price of 200,000 doses was 400 million euros according to the German Health Minister.
If you divide it, it will be 2,000 euros per dose, that is, more than 20,000 NOK.
The Ministry of Health and Care Services stated in early February that Norway had been offered to participate in a joint procurement of the medicine through the EU and expressed interest in doing so.
– It will attack the virus immediately.
In the decision the EMA made on Friday, they provide advice on how the drug can be used before approval.
They write that It can be given to patients over 12 years of age who are infected with COVID-19 and who do not need oxygen treatment, but who are at high risk of a serious course of the disease.
Because this drug works in a similar way to a vaccine, it has been discussed whether it can also be given as a preventive treatment. But in studies, the drug has been given mainly to infected patients and the EMA does not recommend it at this time.
Steinar Madsen from the Norwegian Medicines Agency emphasizes that such a medicine cannot in any way replace the vaccine, although it can be a useful adjunct to vaccination.
– The difference between this and a vaccine is that it will work immediately, because it adds ready-to-use antibodies to the spike proteins. With a vaccine, it will usually take 2 to 3 weeks before it has an effect from the first dose, he says.
With a vaccine, the immune system responds and forms antibodies on its own, and then the body also “learns” until the next time it is exposed to an infection.
– Here the antibodies are added. The antibodies will immediately attack the virus and help prevent the virus from entering the cells of the body.
Antibodies break down in the body over time. The antibody drug could have an effect for 6 to 8 weeks, Madsen previously explained.
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Currently, there are two drugs approved for the crown in the EU and Norway: Remdesivir, about which there has been much disagreement, and Dexamethasone. Madsen has previously stated that Remdesivir has not been widely used in Norway. The Norwegian Medicines Agency does not have figures on how much dexamethasone has been used, because it is used for other things as well.
There are several antibody treatments, but the one that has advanced the most through the approval process in the EU is the drug developed by Regeneron.
The drug is still being considered for approval; it is under what’s called an “ongoing review,” in which the company continually submits data to the EMA scientific committee.