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Studying Remdesivir
The Swedish Medicines Agency is studying raw data on Remdesivir together with the German authorities. Together, they have been given the responsibility to make a decision on the use of the drug on behalf of the entire EU. Bergquist claims that Norway will also be included in the decision.
– What will this approval include?
– It is difficult to answer. There may not be any approval at all. At the same time, it is too early to say which group of patients should include any approval. It must be considered first and foremost.
Recently, a Chinese study of Remdesivir for the treatment of Covid-19 was published in the acclaimed journal The Lancet, which it found to have no significant effect. On the other hand, the US National Institute of Health. USA (NIH) has shown promising results in a study that has not yet been published.
Bergquist adds that Remdesivir has also been studied for the treatment of Ebola patients in the past, and that there are several ongoing studies on the drug.
– Are you optimistic?
– It is a complex question and it is not clear what the data shows. There will be more data, so we’ll see, she says.
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bad interpretations
It was in an interview with Swedish TV4 that Bergquist made statements that were misinterpreted in the Swedish media.
– We evaluate the benefit against the risk. It goes as fast as possible. They even work this weekend. This is a very high priority and is done as quickly as possible.
– Could it be in a matter of days? asks the TV4 reporter.
– It’s hard to say a date. It’s probably … yes … there are extreme circumstances, so it will go fast, Bergquist told TV4.
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Norwegian experts
Dagbladet confronted Research Council CEO John-Arne Røttingen with the original Swedish reports. He was very skeptical.
It will surprise me. I haven’t heard anything about a process starting around you. Such approval should normally be made as a result of the pharmaceutical company requesting the European Medicines Agency. Such approvals do not occur for all countries in Europe.
The Medical Director of the Norwegian Medicines Agency, Steinar Madsen, states that it is possible to obtain temporary approvals for the use of medicines in emergency situations.
– Similarly, we have approved that Remdesivir be used as a treatment against Covid-19 in Norway in an investigative context. If hospitals want to use a drug in connection with research, then they request it from the National Medicines Agency, we also have a scheme that allows us to approve the use of the drug in that context, Madsen tells Dagbladet.
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Tested in Norway
The Research Council leads the WHO global study on Remdesivir. The drug is also being tested in patients at the University of Oslo Hospital and the University of Haukeland Hospital as a result of the Norwegian part of the study.
– Will such approval give very limited use of the medicine?
– It depends on the hospitals how they will use the medicine, says Madsen and continues:
– It is very important not to start using Remdesivir widely in the treatment of patients with Covid-19 outside of clinical trials. This is because it could destroy the results of the investigation. Now we need first level studies, which give us sure answers.
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