Remdesivir is developed by Gilead Sciences Ireland CU and is given by infusion (drip) into a vein.
The fact that an evaluation has been started only means that the data on remdesivir are being reviewed and does not yet say anything about possible benefits and whether they outweigh the risks.
Ongoing evaluation is one of the regulatory tools available to the Agency to accelerate the assessment of a promising investigational medicinal product during a public health emergency, such as the ongoing pandemic.
Under normal circumstances, all data supporting an application for a marketing authorization should be submitted at the beginning of the assessment procedure. In the case of an ongoing evaluation, reviewers are appointed while development is still ongoing and the Agency will assess the data as it becomes available.
It is expected that this procedure will enable EMA to complete its assessment significantly earlier than a regular evaluation procedure, while ensuring that sound scientific advice is obtained.
The CHMP's decision to initiate the ongoing evaluation of remdesivir is based on preliminary results from the ACTT study, showing a potential beneficial effect of remdesivir in the treatment of hospitalized patients with mild to moderate or severe COVID-19. However, EMA has not yet evaluated the full study, and it is too early to draw conclusions about the relationship between the risks and benefits of the medicine.
Any new data that becomes available for evaluation during this ongoing evaluation should be considered in the context of all other existing data. EMA will evaluate all data on remdesivir, including evidence from a recently published study from China and other clinical studies, and reach a conclusion on the benefits and risks of the medicine as soon as possible.
Although remdesivir is not yet approved in the European Union, it is available to patients through clinical studies and so-called compassionate use programs that allow patients to access unauthorized medicines in emergency situations.