RIO DE JANEIRO, BRAZIL – The drug Regkirona (regdanvimabe), which aims to treat early cases of Covid-19, will reach Brazil on Friday, September 3. The product was approved for emergency use by the Brazilian Health Regulatory Agency (ANVISA) on August 11 and should have its use restricted to hospitals – public and private.
Regdanvimab is a monoclonal antibody, that is, it is a product produced in a laboratory that reproduces the body’s defenses capable of helping to fight a specific disease.
The company points out that the drug will not be sold in pharmacies, does not work as an early treatment for Covid-19, and will be used exclusively in hospitals.
The first batch of the drug to reach Brazil should contain 1,200 doses imported from South Korea. The Asian country is the main headquarters of the drug’s manufacturer, Celltrion Helthcare biopharmaceutical company, which sells anti-cancer drugs in Brazil, such as Trastuzumab (monoclonal antibody used in the treatment of breast cancer), Rituximab (another monoclonal antibody used in the treatment of lymphomas and leukemias), and Infliximab (a drug used in the treatment of autoimmune diseases such as rheumatoid arthritis and Crohn’s disease).
In Brazil, the company has not yet disclosed the price of the drug, which should be set after the release of its first batch by ANVISA. In practical terms: the agency must check all documentation, quality control reports, among other criteria, before releasing the drug for distribution in the country. This is a common procedure for all imported drugs.
Regarding customers, the company says it is starting negotiations with public and private entities and is yet to close sales of the drug.
Despite the low number of doses imported this month, the company guarantees that it has the capacity to import much larger volumes, capable of serving the Brazilian population as a whole. “For now, it is still not possible to import the technology to produce the drug in Brazil, but we have a wide distribution network here and we want to increasingly expand the drug’s presence in the country,” says Michel Batista, Celltron’s senior business manager in Brazil.
The main purpose of Regdanvimab is to be used in high-risk patients (elderly with comorbidities, people with BMI over age 35, with immunosuppressive diseases, and with lung and respiratory diseases), as soon as Covid-19 infection is confirmed. “The earlier the better. In our studies, we found that a 7-day course of treatment produced satisfactory results,” Michel says.
In phase 3 trials conducted by the company with 1,315 patients, 72% of them did not progress to a severe case of the disease, and those who needed hospitalization had a reduced stay. This result was presented at the European Congress of Clinical Microbiology & Infectious Diseases in 2020.