It is through large randomised clinical trials that we can obtain reliable information on the benefits and risks of using a drug.
When performing clinical trials of candidate treatments, it is permitted to test completely new medicines without market authorisation or 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
Applications relating to indications of covid-19 are prioritised and processed as quickly as possible. This also applies to CUP applications when the indications relate to 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 (CUP, named patient).
- Pharmacovigilance: evaluates safety documentation before and after granting marketing authorisation.
Therapeutics/medicines approved by EMA for the treatment of covid-19:
: has been granted a conditional marketing authorisation. It is an antiviral drug originally developed for treatment of hepatitis C. Previously tested for Ebola virus.
On 3 July this year the European Commission granted a market authorisation for remdesivir (Veklury) for the treatment of COVID-19. This approval will also apply in Norway. However, it will be the clinicians decision whether and how to use remdesivir (Veklury) to treat patients with covid-19 disease in Norway.
Some of the medicines currently being tested in several major clinical trials are:
This is not an exhaustive list. The Norwegian Medicines Agency has not made a complete assessment of the data currently presented globally.