Some of the treatments are new whilst others can be defined as ‘old’ because they have already been approved for other conditions, but nevertheless demonstrate effect against covid-19.
Medicinal products are being developed to treat different stages of the disease:
- To prevent covid-19 either before or after exposure to those who are ill with covid-19
- To use when infection has been demonstrated, in order to prevent progression to severe disease.
- To use in hospitals for the treatment of severe covid-19.
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.
Several therapeutics/medicines are authorised for use in the EU/EEA, and some treatments are under evaluation by the European Medicines Agency.
See details on EMAs webpage