COVID-19: Portugal has already concluded processes for the acquisition of drugs committed by the EMA – News
The two drugs Ronapreve and Regkirona are the monoclonal drug drugs to receive a positive opinion, according to the European regulator, explaining that the monoclonals “are proteins designed to attach to a specific target, in this case the peak protein of SRA-CoV-2, that the virus uses to enter human cells”.
Asked today at a press conference about the process of vaccination against the flu and covid-19, whether Portugal was going to acquire these drugs, the general director of Health, Graça Freitas, said yes.
“Infarmed is the entity primarily responsible, but always with our support, and we already have the processes completed for centralized acquisition, and we can also have access via non-centralized acquisition, via the country only,” said Graça Freitas.
According to Graça Freitas, Portugal “always monitors a lot” the issue of medicines within the scope of “two very important components, the European mechanisms”, but also the capacity that each country has to be able to acquire these medicines.
Regarding the antivirals that are still being studied by the EMA, a general health directive stated that the European Commission has already started the process for centralized procurement.
The process always begins with forecasting the need, he said, explaining that each country has to estimate what it will need for its population, since Portugal is at this stage.
“The DGS is doing as we highlighted and then with Infarmed we will continue the process”, he said, adding that Portugal is in “all lines for the acquisition” of medicines.
“Our mission is to guarantee that when there is an effective vaccine or medicine, a population residing in Portugal has access to that medicine or that vaccine”, commented Graça Freitas.
The two drugs taken are Ronapreve (casirivimab / imdevimab) and Regkirona (regdanvimab), the first by pharmaceutical company Roche, Switzerland, and the second by Celltrion Healthcare, in South Korea.
For Ronapreve, the EMA recommends authorization for the treatment of covid-19 in adults and adolescents (from 12 years old and weighing at least 40 kg), who do not need supplemental oxygen and who are at increased risk of their disease becoming serious.
The drug can also be used to prevent covidosis 19 in people over 12 years, says the EMA on its official website.
As for Regkirona, the EMA also recommended authorizing the drug to treat adults with covid-19 who do not need oxygen supplementation and who are also at increased risk of their disease becoming severe.
The EMA says it has looked at data from studies showing that drug therapy reduces hospitalizations and deaths in covid-19 patients.