Procedure for accelerated and conditional approval has proved successful / First important step / Commission should grant approval at short notice

"The European Medicines Agency on Thursday has recommended granting a conditional marketing authorisation for the treatment of Covid-19 with Remdesivir. This is an important step towards the treatment of corona patients in Europe and the first time a drug against the corona virus will be available". This was said by MEP Peter Liese, spokesperson of health of the biggest group in the European Parliament (EPP, Christian Democrats).

Conditional marketing authorisation means that the experts believe that the drug is probably effective and has low side effects, but that it is still necessary to investigate carefully during treatment whether this assumption is correct. In order to better prove the efficacy and safety of Remdesivir, the company must submit the final reports of the Remdesivir trials to the EMA by December of this year.

Peter Liese demands further investigations, in particular to find the optimal time and the optimal dosage form for Remdesivr. "According to many experts, it is important that Remdesivir is given at a relatively early stage of the disease, when the spread of the virus still plays a relatively large role. In the final stage, other drugs such as Dexamethasone work better because it is not the virus that determines the course of the disease, but a kind of autoimmune reaction. It is therefore important to find the right time and perhaps a form of administration via the respiratory tract is more effective than the previous form of administration”, Liese said.

The data on Remdesivir have been evaluated in an exceptionally short period through a so-called rolling review mechanism, an approach that the EMA uses in public health emergencies to evaluate the data as soon as they become available. "The crisis mechanisms for a fast yet safe conditional approval of drugs in extraordinary crises have proven to be effective. I believe that the conditional marketing authorisation of Remdesivir is the right one. It is good news for many patients. Research to date has shown that Remdesivir can reduce the course of the disease, perhaps even reduce the death rate, and that the side effects are acceptable. However, we must continue to monitor closely and analyse the data continuously. It is important that the drug is now available in sufficient quantities. The company has personally assured me that it will make Remdesivir available to European patients once conditional marketing authorisation has been granted. I am pleased that this can now happen in a few days," said Liese.  Formally, the European Commission still has to officially grant the approval. "I am sure that this will happen promptly," Liese concluded.