Brazil’s health regulator approves emergency use of two coronavirus treatment drugs

RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (ANVISA) on Thursday, May 13, unanimously approved the use of two drugs, the monoclonal antibodies banlanivimab and etesevimab, for the treatment of coronavirus patients in the country.

The decision was announced during an extraordinary meeting and is of an emergency nature, with temporary authorization to meet the demands of the pandemic.

The associated antibodies are prescribed for adults and pediatric patients, over 12 years of age and weighing more than 40 kilos, with laboratory-proven infection and who are in the high-risk group for the disease (comorbidities, advanced age, obesity, etc.). However, ANVISA stressed that the treatment should not be administered to patients with a severe case of the disease, as this could “worsen the clinical outcome.”

Produced by Eli Lilly do Brasil Ltda., these drugs are prescribed as soon as the coronavirus is identified in the body and up to ten days after the onset of symptoms. ANVISA further stressed that the use is restricted to hospitals, under medical prescription, and can not be sold in pharmacies. According to the clinical trial submitted to the agency, the treatment reduces the relative risk of Covid-19 by up to 70%.

The recommended dosage is 700 mg of banlanivimab and 1,400 mg of etesevimab, administered through intravenous infusion (solution applied in the vein). However, there is still no data to ensure the efficacy and safety of the treatment in patients under 18 years of age or pregnant women. The use in children should be based on pharmacokinetic evaluation.

There is also no evidence of safety or efficacy of the treatment against the P.1 variant, initially identified in Manaus. Nevertheless, the agency stated that the information at hand so far is “satisfactory” for use in this case.

Authorized abroad

The treatment was authorized in February by the U.S. Food and Drug Administration (FDA). In March, it was also approved by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

This is the third treatment that ANVISA approves to fight Covid in the country. In March, the agency allowed the use of remdesivir in coronavirus patients. The following month it also approved the combination of two other monoclonal antibodies – casirivimab and imdevimab.

In her vote, ANVISA director Meiruze Sousa Freitas pointed out that there is still no final registration for the drugs and that further trials are still needed regarding their potential effects or contraindications. “During this public health emergency, the temporary authorization for emergency use is a regulatory instrument to timely foster the offer of therapeutic options, even when faced with a product in clinical development,” explained the director.

“ANVISA’s decision is based on and supported by the consideration of its potential benefits to public health, compared to potential risks arising from the health action,” she added. Furthermore, she said that the data presented showed that the drug combination did not result in serious complications. Hence the assessment that “the risks seem to be manageable.”

How does it work

The combination of the monoclonal antibodies banlanivimab and etesevimab acts by blocking the binding of the coronavirus spike protein to human receptors and, consequently, preventing the entry of the virus and its replication in human cells. However, the treatment is not indicated for the prevention of the disease or for severe cases.

In March, the U.S. government signed a contract for the initial purchase of 100 thousand doses of the drug combination, for US$2,100 each dose (about R$ 11,100).

Also according to ANVISA, its emergency use approval in Brazil implies that this treatment will be preferentially incorporated into the Brazilian National Health System (SUS). On the other hand, nothing prevents it from also being used in the private network.