Anvisa goes back and cancels approval for nasal spray against Covid

Anvisa (National Health Surveillance Agency) canceled the release of the nasal spray against Covid in Brazil this Wednesday (19).

The regulatory agency had granted Belcher Farmacêutica’s request authorizing the importation and distribution of Taffix on December 30th. The spray is manufactured by Israeli biopharmaceutical Nasus Pharma.

The product description says that it can be used to block several respiratory viruses, including coronavirus, inside the nasal cavity.

The regulatory agency, however, found that no clinical studies were presented to prove this claim, which makes it necessary to immediately cancel the release. The decision will be published in the Official Gazette this Wednesday (19).

According to Anvisa, the requested product authorization does not require prior technical analysis for the regularization of the product. Upon release, an audit proved that the product did not match the description due to a lack of efficacy studies.

The regulatory agency clarified that responsible companies that wish to regularize antiviral sprays must prove all proposed indications for use through clinical studies.

Belcher’s forecast was that the first batch of Taffix would arrive in Brazil in February and would be available in pharmacies from the last week of the month. The pharmaceutical informed that the product is marketed in more than 30 countries.

According to the company, after applying the spray, an ultra-thin gel layer is formed on the nasal mucosa. This protection would prevent up to 99% of the viruses from entering the cells present in the nose, the main gateway for the transmission of Covid-19 and other viral diseases.

“This protective layer is formed in 50 seconds and ensures continuous protection against viruses for 5 hours. The protection mechanism has been proven in several laboratory studies, including those carried out at the University of Virginia and the Israeli Ministry of Health,” he said. in note the laboratory.

The product is not the same as announced by President Jair Bolsonaro (PL). Last year, the president announced that the EXO-CD24 nasal spray, originally developed to fight ovarian cancer, was to be tested in Brazil against Covid-19.