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Anvisa grants registration to unpublished remedy for spinal muscular atrophy

Anvisa grants registration to unpublished remedy for spinal muscular atrophy

The National Agency of Sanitary Surveillance (Anvisa) granted the registration to the drug Spinraza, directed to patients with Muscular Atrophy Spinal (AME), a degenerative disease that affects the control of nerve movement, preventing body movement and even breathing. It is estimated that one in ten thousand babies is affected by atrophy.

The decision should be published on Monday (28). The medicine can be purchased as an injectable solution with a concentration of 2.4 mg / ml. The medicinal product is manufactured by Vetter Pharma - Fertigung GmbH & Co. KG, Germany, and Patheon Italy S.PA, Italy.

According to the agency, the registration process of the drug received priority analysis as soon as it was filed with Anvisa, with the immediate beginning of the evaluation of both the documentation related to the proof safety and efficacy as well as the dossier of pharmaceutical technology.

"It is a medicine that changes the history of AME, giving a concrete possibility of a significant improvement in the quality of life of patients with this disease," said Anvisa's CEO , Jarbas Barbosa.

As an unprecedented substance in the country, the approval process was complex and involved a critical evaluation of technical and legal information. Anvisa said that it has placed a priority on registration, with approval five months after the request of the pharmaceutical company.

The agency has not yet determined what the price of the drug will be, but it is expected that Spinraza will be sold for a more affordable value in Brazil. Some Brazilians who managed to import it had to pay R $ 3 million for the first year of treatment, which consists of six doses.

With Anvisa Information

Understand What is Spinal Muscular Atrophy

There are four main types of muscular atrophy. The most serious is Type 1, also known as Werdnig-Hoffmann disease. It may manifest from the intrauterine phase to six months of age. During pregnancy it is possible to observe little movement of the fetus. When the baby is born the most characteristic symptoms are marked muscle weakness, sucking and swallowing problems and breathing difficulties. The constant respiratory complications are the main causes of death by the disease.

The diagnosis of spinal muscular atrophy should be made through genetic tests in patients with loss of muscle strength and proximal hypotonia. The disease has no definitive cure. However, the use of orthopedic appliances, special appliances, along with physical therapy can benefit patients, preventing complications such as scoliosis and providing a better quality of life and autonomy for children.


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