The two drugs Ronapreve and Regkirona are the first monoclonal antibody drugs to receive a positive opinion, according to the European regulator, explaining that the monoclonal antibodies “are proteins designed to attach to a specific target, in this case the spike protein of SRA-CoV- 2, which the virus uses to enter human cells”.
Asked 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 concluded for centralised acquisition, and we also managed to have access through non-centralised acquisition, through only our country”, said Graça Freitas.
According to Graça Freitas, Portugal “always monitors” the issue of medicines within the scope of “two very important mechanisms, 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, the Director-General of Health added that the European Commission has already started the process for centralised acquisition.
The process always starts with forecasting needs, she said, explaining that each country has to estimate what it will need for its population.
"The DGS is making the estimates and then with Infarmed we will continue the process", she said, stressing that Portugal is in "line for the acquisition" of medicines.
“Our mission is to guarantee that when there is an effective vaccine or medicine, the population residing in Portugal has access to that medicine or to that vaccine”, concluded Graça Freitas.
The two approved drugs 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 recommended authorization for the treatment of Covid-19 in adults and adolescents (from 12 years and weighing at least 40 kg) who do not need supplemental oxygen and who are at increased risk.
The drug can also be used to prevent Covid-19 in people over 12, says the EMA on its official website.
As for Regkirona, the EMA also recommended authorising the drug to treat adults with Covid-19 who do not need supplemental oxygen and who are also at increased risk of their disease becoming serious.
The EMA says it has looked at data from studies showing that treatment with the two drugs significantly reduces hospitalisations and deaths in patients with Covid-19.