The anti-Parkinson drug produced by Fiocruz becomes a national reference

With the determination, the laboratories that want to produce the medicine must follow the quality parameters established by the institution

Used for the treatment of Parkinson’s diseasethe medicine pramipexole dihydrochloride, produced by the Institute of Pharmaceutical Technology (Farmanguinhos) of Oswaldo Cruz Foundation (Fiocruz), has become a national reference for any laboratory interested in producing it in Brazil, as announced by the institution. Production is permitted in concentrations of 0.12 mg, 0.250 mg and 1.0 mg. Inclusion in list of reference medicines of the National Health Surveillance Agency (Anvisa) it happened last Friday, the 8th.

“Receiving this designation from Anvisa attests to the quality, effectiveness and safety of Farmanguinhos medicines, providing safety to healthcare professionals and patients using medicines through the Unified Health System (SUS),” says Juliana Johansson, head of the department of Management of technological development in Farmanguinhos/Fiocruz.

Among the criteria that led to this measure is the fact that the reference medicine previously present in the list, ?Sifrol,? is no longer available on the Brazilian market,? due to the? cancellation request? by the company pharmaceutical?Boehringer Ingelheim. To guarantee national autonomy in the production of the Parkinson’s drug, Fiocruz had already entered into a partnership with the German pharmaceutical company. The announcement took place on March 30, 2022.

On the occasion, the president of Boehringer Ingelheim do Brasil, Marc Hasson, stated that the Production Development Partnership (PDP) is extremely important for national autonomy in the production of medicines. “In this way, patients suffering from Parkinson’s disease can benefit from and have access to treatment,” he stressed.

According to Farmanguinhos/Fiocruz, to implement the production of pramipexole on an industrial scale, the institute involved expertise from different sectors, such as the pharmaceutical technology laboratory, packaging development, management assistance in technology absorption and transfer projects , as well as quality control areas. , Production, Good Manufacturing Practices Service, among others.

According to World Health Organization (WHO), it is estimated that more than 200,000 people live with the disease in Brazil. The medicine offers benefits to the patient, as it stabilizes the disease and provides a better quality of life. OR Parkinson it is the second most widespread neurodegenerative disease in the world, second only to that Alzheimer’s.

What is Parkinson’s disease?

It is a chronic and progressive degenerative disease of the central nervous system. It is caused by the degeneration of the cells they produce dopamine in a region of the brain. According to the Ministry of Health, the substance is important for the proper functioning of the central nervous system and its reduction or absence causes problems in the movement of the body’s muscles.

Symptoms include:

• Tremors;
• Slowness of movements;
• Muscle stiffness;
• Changes in speaking and writing.

Fiocruz notes that the symptoms negatively affect the quality of life of the population affected by this pathology. As a result, comorbidities related to emotional problems are also common. “Dealing with the daily routine becomes a challenge and continuous pharmacological support is a crucial point to manage symptoms and slow down the progression of the disease, ensuring greater longevity for patients.”

The disease can affect anyone, regardless of sex, race, color or social class. However, it tends to affect older people. According to the Ministry of Health, most people experience the first symptoms after the age of 50.

What is a reference medicine?

A reference medicine is an innovative product, registered and marketed in the country, whose effectiveness, safety and quality have been scientifically proven with Anvisa at the time of registration. to see the list of reference medicines.

“The reference medicine is a state granted to the medicine which becomes a parameter of therapeutic efficacy, safety and quality for the registration of generic and similar medicines”, adds the regulatory agency.

Source: Terra

Ben

Ben Stock is a lifestyle journalist and author at Gossipify. He writes about topics such as health, wellness, travel, food and home decor. He provides practical advice and inspiration to improve well-being, keeps readers up to date with latest lifestyle news and trends, known for his engaging writing style, in-depth analysis and unique perspectives.