It is through large randomised clinical trials that we can obtain reliable information on the benefits and risks of using a candidate treatment .
When performing clinical trials of candidate treatments, it is possible to test new medicines that do not yet have a marketing authorisation or to use medicines that have already been tested and approved for other diseases. Although the medicine may have been approved for other diseases, it is uncertain whether the same dosage and treatment regime can be used when testing the medicine on covid-19 patients. Other types of side effects may also emerge and with a different scope than previously identified.
Testing should be conducted as clinical trials
Clinical trial applications relating to covid-19 are prioritised and processed as quickly as possible. This also applies to CUP applications for covid-19. In some situations, rapid treatment is required for seriously ill patients and this is not possible within the boundaries of a clinical trial. In such an event, the Norwegian Medicines Agency will carry out a rapid assessment of applications for compassionate use, named patient.
The role of the Norwegian Medicines Agency:
- Provides scientific advice.
- Processes applications for clinical trials in Norway.
- Processes applications for marketing authorisation of medicines; as centralized approvals through EMA or national approvals (in Norway).
- Processes applications for the use of drugs without a marketing authorization (either through compassionate use programme (CUP) or compassionate used named patient).
- Pharmacovigilance: evaluates safety documentation before and after granting marketing authorisation.
Several medicines are being tested in clinical trials as potential treatments for covid-19. The majority of the treatments affect the immune system or act on the SARS-CoV-2-virus.
Therapeutics/medicines authorised for use in the EU/EEA
has been granted a conditional marketing authorisation. It is an antiviral drug originally developed for the treatment of hepatitis C and also previously tested for treatment of Ebola.
On 3 July 2020 the European Commission granted a marketing authorisation for remdesivir (Veklury) for the treatment of covid-19. This approval also applies in Norway. However, it is the clinician’s decision whether and how to use remdesivir (Veklury) to treat hospitalised patients with covid-19 in Norway.
Treatments under evaluation by the European Medicines Agency (EMA)
The European Medicines Agency (EMA) is evaluating potential covid-19 treatments to enable promising medicines to reach patients in the EU/EEA as soon as possible.
For most of them, EMA has issued “advice on treatments that are not yet authorised specifically for patients with covid-19”.