How did it happen that Paracetamol was suddenly in short supply?
Coronavirus German institute hopes Covid-19 treatment will be approved this year
Bonn · The president of the Federal Institute for Drugs and Medical Devices, Karl Broich, has expressed hope that a drug to treat Covid-19 will be approved this year. The results of clinical studies are still pending.
11.04.2020
, 09:28 Uhr
German research institutions are also actively participating in the WHO's Solidarity drug study on Covid-19. Research Minister Anja Karliczek (right), Professor Susanne Herold (University Hospital Gießen) and Professor Hans Georg Kräusslich (University Hospital Heidelberg) presented the project on Thursday. Photo: obs/Hans-Joachim Rickel
Foto: obs/Hans-Joachim RickelGermany can hope for the approval of a drug to treat Covid-19 caused by the novel coronavirus before the end of this year.
The President of the Federal Institute for Drugs and Medical Devices (Arzneimittel und Medizinprodukte), Karl Broich, said in a GA interview that within a few weeks, his agency will have the first really well-documented data from Germany. It comes from clinical studies in which active substances for the treatment of Covid-19 are being tested. "If the data are conclusive, I am very confident that we will be able to grant approval before the end of this year," said Broich.
He added in a qualifying statement: "So far we have not had sufficient proof of efficacy for any drug."
Here are some selected excerpts from the interview:
Broich: The World Health Organization (WHO) unfortunately accepted reports that ibuprofen could be harmful to Covid-19 patients, and that paracetamol should be the preferred painkiller. This has not been scientifically proven and has since been withdrawn by the WHO. Still, some people went out panic buying the medicine. That is why we decided together with the Federal Ministry of Health that only one package of paracetamol per patient would be dispensed.
What seems to be the most promising treatment for Covid-19?
Broich: Several clinical trials are underway with the active substance Remdesivir, which is a virus-inhibiting agent that is considered to be the most promising from the preclinical data and has also been recommended by the WHO. Eight clinical centers in Germany are involved in these trials. We approved these trials within one day.
Can Remdesivir already be used outside clinical trials?
Broich: Because we already have so many Covid-19 patients, we approved a so-called hardship treatment on April 3. This means that severely affected patients with covid disease can be treated with Remdesivir outside a clinical trial in hospital, although it has not yet been officially approved. All this is happening without neglecting safety standards. We take great care to ensure that even with these quick decisions we have the best possible chance of efficacy, but at the same time we want to protect patients as best we can so that they do not suffer any side effects.
You already mentioned hydroxychloroquine, which is related to chloroquine and has been used against malaria. How does the BfArM evaluate these two drugs so far?
Broich: Both of them were used a great deal in China during the epidemic there. We have also received the first clinical study results from China, but they were methodologically very vulnerable. So far, there is no drug that has sufficiently proven its efficacy and harmlessness in Covid-19 disease. However, some data suggest that chloroquine could help, especially if used early.
What are the health risks of chloroquine and hydroxychloroquine?
Broich: Both drugs can, for example, have a negative effect on heart rhythm. In France, there have recently been deaths due to uncontrolled self-administration of chloroquine by patients who have had serious interactions with other drugs. That is why it is so important for us to use all our communication channels, on our website, in the media, to make it clear: Despite all the hardship of Covid-19 disease, it's all about making sure the treatment is safe. We must not lose our nerve and try all kinds of things, instead we must take an orderly approach so that we can obtain well-founded scientific data for approval as quickly as possible and at the same time enable patients to access treatment options. This has been a high priority for us over the past two weeks, and we have made very good progress in this respect, even by European standards.
When might there be an approved drug for Covid-19?
Broich: I assume that we will receive the first reliable results from the ongoing studies by late summer. If the data is indicative, I am very confident that we will be able to grant approval before the end of this year. But it is also clear that we do not yet have sufficient proof of efficacy for any drug. We know from the Chinese experience, for example, that there are initial positive indications for Remdesivir. But there are also question marks. That is why we are also contributing our technical expertise as the lead authority in the evaluation of Remdesivir at European level for the benefit of patients.
(Orig. text: Ulla Theide / Translation:ck)
