The new medicine was recognized by Anvisa after studies at the Institute of Technology in Pharmaceuticals, the Oswaldo Cruz Foundation
The Institute of Pharmaceutical Technology (Farmanguinhos), of the Oswaldo Cruz Foundation (Fiocruz), has become this year a point of reference for the drug Primaquine 5mg, intended for adults and children from 6 months of age, in the treatment of malaria.
The recognition took place in February, but the information was released last Friday (19) by Fiocruz. The public health technologist and head of the technological development management department of Farmanguinhos/Fiocruz, Juliana Johanssonhe said the institute had already supplied the Ministry of Health with 15mg and 5mg of Primaquine.
“The distribution of Primaquine 5 mg started in February 2023 and the 15 mg one we have been distributing since 2022. With this, we ensure that the country has autonomy in the treatment of malaria”.
The next steps are to continue receiving requests from the Ministry of Health for the procurement of the Unified Health System (SUS), through the National Program for the Prevention and Control of Malaria (PNCM). Studies for Primaquine 5mg started in 2014, along with the development of Primaquine 15mg. “It was a very complex and successful project from a technological point of view, because we have now managed to register with Anvisa and become a reference drug”highlighted Johansson.
Laboratories
Since the inclusion of the drug manufactured by Farmanguinhos in the Anvisa list, any laboratory wishing to register or regularize its product before the agency must demonstrate interchangeability with the institution’s product, through a bioequivalence study. Being a reference medicine means that the institute has had its quality assured by the regulatory agency and evidence of efficacy, safety, stability of the medicine has been demonstrated, ensuring patient safety and treatment efficacy.
“We have become a level of quality to be achieved. It is a parameter, it is an example, a model of what must be achieved in terms of quality”. The laboratories will have to demonstrate to Anvisa the similarity, the pharmaceutical equivalence with respect to the drug Farmanguinhos. “Prove that they have the same behavior as our medicine”ranked Juliana Johansson.
Malaria
In South America, Brazil is the country with the highest number of cases of malaria. In an epidemiological bulletin published in April 2023, the Ministry of Health reported that, in 2021, 193,000 cases of the disease were recorded in Brazil, with 58 deaths. In 2022 there were 129,000 cases and 50 deaths. Preliminary data from the file show that, in the first two months of 2023, 21,273 cases have already been registered, an increase of 12.2% compared to the same period last year.
The infectious disease affects adults and children equally and is transmitted by the bite of infected female mosquitoes. anopheles (nail mosquito). The causative agent of the disease is such a protozoan Plasmodium. These mosquitoes are most abundant at dusk, dusk and dawn.
The symptoms of malaria are high fever, chills, shivering, sweating and headache. There are people who, before presenting these manifestations, experience nausea, vomiting, tiredness and lack of appetite. The Ministry of Health warns that malaria is a curable disease with effective, simple and free treatments. However, the file highlights that the disease can progress to serious forms and even death if it is not diagnosed and treated in a timely and adequate manner.
Source: Terra
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