The director of the European Medicines Agency, Guido Rasi, has opened the door to apreliminary authorization in the EU of the medicine remdesivir, developed by the Gilead company, astreatment for Covid-19, although always subject to its experts judging that the data from the trial in the United States are “solid” enough.
“It may be that aconditional authorization in the next few days, based on the data presented and the analysis of the experts on whether they are solid enough, “explained the Italian before the Committee on the Environment and Public Health of the European Parliament.
This type of authorizations are granted by the EMA to medicines in whichthe benefits of its use outweigh the riskthat there is less data than what is normally required for full authorizations, according to the organization on its website.
So far, the EMA has only published“guidelines” on the “compassionate” use of remdesivir,an option that allows the use of a drug that does not yet have a marketing authorization under “strict conditions”.
With respect to other treatments that the EMA is studying, its director has indicated that “the fastest” are based on monoclonal antibodies, but he does not wait for their authorization “in the short term”.
In relation to a possible vaccine, Rasi has stressed that evenif the EMA authorizes the use of any in the future, the agency is not able to guarantee its availabilitythroughout the community block. In this context, he emphasized, it will be “key” to develop a European “model” to identify segments of the population that can be progressively vaccinated.
“What comes will not be a production that allows the availability of vaccine doses worldwide. That is why we need to have aholistic model that every European country, and perhaps from outside Europe, with the same approach, can identify in waves the populations most likely to benefit and vaccinate them, creating a first line of defense, “he proposed.
“A solid model that everyone has to follow. This rational approach will ensure that with the number of doses we can achieve the highest protection in a large population,” said the director of the EMA.