Currently, the worldwide priority is to help saving lives during the COVID-19 pandemic, therefore, the availability of a drug and vaccination to treat and prevent the COVID-19 is strongly needed.
However, the regulatory agencies, including also the European Medicines Agency (EMA), have to make sure the efficacy and safety of the treatments available for the patients for the benefit of public health.
All medicines must be authorised before they can be administered to patients. If the benefits of the medicine are greater than the risks, then the drug can be marketed.
First, scientists develop a medicine that they think could treat a specific disease. Once it passes the lab tests, it has to be tested on humans through clinical trials to make sure that the medicine is safe and works as expected. In particular, there are 4 main phases to be followed:
Among the potential treatments for COVID-19, tested in clinical trials aimed to assess their safety and efficacy, there are:
- Remdesivir (investigational)
- Lopinavir/Ritonavir (currently authorised as an anti-HIV medicine)
- Chloroquine and Hydroxychloroquine (currently authorised at national level as treatments against malaria and certain autoimmune diseases)
- Systemic interferons and in particular Interferon beta (currently authorised to treat diseases such as multiple sclerosis)
- Monoclonal antibodies with activity against components of the immune system
Moreover, two potential vaccines have already entered the phase I clinical trials.
Some of the experimented drugs have been already authorised and used for other diseases; therefore, the drug repositioning process can take place. This process enables to accelerate the discovery of a treatment for COVID-19, without excluding the necessity to provide with evidences supporting the drug efficacy and safety.
The fight against the COVID-19 is ongoing but we still have to learn more on how to manage it.
Discover more about the European authorisation process by watching the EMA video.
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