EMA recommended granting conditional MA to Remdesivir
Seems that first approved COVID treatment will go through registration
Great news are coming from EMA – European Medicines Agency – as they have recommended granting a conditional marketing authorization to Veklury, which is better known under its Active Pharmaceutical Ingredient name called Remdesivir for the treatment of COVID-19. The granting recommendation was provided by EMA in exceptionaly short timeframe by taking into consideration the available data where the agency considered that the balance of the benefits and risks have been positive in patients with pneumonia.
The European Commission, which was kept informed by EMA throughout the evaluation, will fast-track the decision-making process and aims to grant a decision on the conditional marketing authorisation for remdesivir in the coming week, allowing the product to be marketed in the EU.
If you are interested in more details please follow the link to original article at European Medicines Agency website below.