Anvisa (National Health Surveillance Agency) approved this Friday (17) the indication of the drug baricitinib for the treatment of hospitalized patients with Covid-19.
The drug was already registered in Brazil for the treatment of rheumatoid arthritis and moderate to severe atopic dermatitis. Now its use will also be included in the package insert for the treatment of the disease caused by the coronavirus.
The new indication is valid for adult patients hospitalized with Covid’s severe condition, who need oxygen support by mask, nasal catheter or mechanical ventilation.
For the inclusion of this new indication, the pharmaceutical company Eli Lilly do Brasil presented data that support the efficacy and safety of the drug for this other use.
Gustavo Mendes, general manager of medicines at Anvisa, said the drug was 38% effective in reducing the mortality of people hospitalized because of Covid-19. Baricitinib works by preventing the virus from replicating and spreading in the cell.
Of all approved so far by Anvisa for Covid, this is the first drug that can be sold in a pharmacy. “In this indication, it is expected that it be used in a hospital environment, but it will not be restricted because it is already marketed,” explained Mendes.
This is the sixth treatment against Covid approved by the regulatory agency in Brazil. The first was Remdesivir, which was registered in March. The medicine is indicated for people hospitalized with pneumonia and who need oxygen support, as long as they are not on mechanical ventilation.
The other is Regen-cov, which consists of a combination of monoclonal antibodies, approved for emergency use. “The drug combo significantly reduced by 70.4% the number of hospitalizations and deaths in a symptomatic laboratory patient with one or more risk factors for serious illness,” Mendes said at the time.
In May this year, the agency approved emergency use of a cocktail developed by the company Eli Lilly. Treatment is a combination of the biological drugs banlanivimab and etesevimab. Due to the need for follow-up in the application, there is no possibility of selling it in pharmacies for use at home.
In August of this year, it was the turn of the drug regdanvimab, from the company Celltrion Healthcare. It is indicated for mild to moderate treatment in adults who do not need oxygen supplementation but are at high risk for Covid progression.
The fifth approved is sotrovimab. The drug is recommended for patients with mild and moderate cases of the disease, but who are at risk of a poor course of the disease.
Anvisa also informed this Friday (17) that it requested the change of the package insert of the Janssen vaccine, a single-dose immunizer against Covid-19.
The change, which needs to be made within 30 days, is intended to include adverse events that were identified during pharmacovigilance monitoring of vaccine use.
The application includes the following adverse events: lymphadenopathy, which means the enlargement of lymph nodes, such as the appearance of lumps in the neck; paresthesia, feeling of numbness in some part of the body; hypoesthesia, decreased skin sensitivity; tinnitus and ringing in the ear; diarrhea and vomiting.