Medicine approved by Anvisa against Covid has a preventive effect, says study

A new study with Regn-Cov2, a drug approved by Anvisa (National Health Surveillance Agency) for mild and moderate cases of Covid, shows that the drug also acts preventively against the disease caused by the coronavirus.

Treatment is a combination of the monoclonal antibodies casirivimab and imdevimab. It is manufactured by pharmaceutical Roche in partnership with Regeneron, responsible for the research.

The cocktail was evaluated in 2,475 people who did not have the disease but were at high risk of becoming infected because they lived in the same household with a person with Covid-19.

The dosage used was 600 mg of casirivimab and 600 mg of imdevimab, the same applied in another study for people with mild and moderate cases of the disease.

“This individual received a dose of this antibody cocktail. He was first evaluated in a month and, with the study segment, it was seen that he was able to offer protection against symptoms of Covid-19 during an eight-month period”, says Mauricio Rocha , medical manager of the Covid-19 portfolio at Roche Farma Brasil.

The new study finds that just one dose of casirivimab and imdevimab was able to reduce the risk of developing symptoms of Covid-19 in 81.6% of people over a period of up to eight months. The results came out this month.

Today, the drug is approved by the regulatory agency in Brazil for emergency use in patients aged 12 or over who have Covid-19 and who are at high risk of progressing to severe forms of the disease.

According to Anvisa, it is not authorized for use in patients hospitalized by Covid or who need high-flow oxygen or mechanical ventilation in their treatments.

According to data from a first clinical study, the antibodies showed no benefit in hospitalized patients, and may even be associated with worse clinical outcomes when used.

Now, according to Rocha, with the results of the new study, the laboratory is preparing the necessary documentation to submit the drug again for analysis by Anvisa.

“We are currently in preparation for regular submission to Anvisa, both from this outpatient population as well as from the prophylaxis scenario [prevenção]. You need another submission for this new nomination,” he says.

According to Rocha, the drug is not yet used in Brazil for outpatient use, as approved by Anvisa, because Roche has adopted a strategy of negotiating only centrally with governments.

Roche’s medical manager says that since April this year, he has had a dialogue with members of the Ministry of Health.

A public consultation was opened at Conitec (National Commission for the Incorporation of Technologies in the Unified Health System) for the incorporation of the drug into the SUS for outpatient cases, but the request was rejected in July.

Now, a new process has been started after an internal demand from the Ministry of Health’s Secretariat for Science, Technology, Innovation and Strategic Health Inputs. Civil society can contribute until December 3rd.

Conitec’s preliminary recommendation was against incorporation into the SUS. According to the agency, there are “limitations in the published studies, due to the short window between the onset of symptoms and the infusion of the drug, which represents a logistical problem for the implementation of the technology in clinical practice”.

The most recent technical report by Conitec traced an expectation of the drug’s impact on public accounts. “The estimated impact of treating elderly or immunodeficient patients (increased risk of vaccine failure) generates an estimated annual savings of R$804,034,746.80”, he says.

Currently, the cocktail is approved in more than 50 countries, either for indication of post-exposure prophylaxis to the new coronavirus, or for outpatient use, in the treatment phase.

Among the countries that already use the drug are the United States, United Kingdom, Canada, Japan, India, Australia, Israel and Switzerland.

Rocha assesses that vaccination is the main pillar of the fight against the pandemic, but that there is a section of patients who do not have a good immune response to an immunizing agent.

“It is very important that there is a therapeutic option for these patients who do not respond adequately to the vaccine. They need this treatment to avoid hospitalization”, he says.