Young Ana Beatriz Stubinski, just 22 years old, who suffered a serious spinal cord injury and spinal fractures after a tree branch fell on her in Curitibain Paraná, received approval from Anvisa for the application of polylaminin.
The information was confirmed by the young woman’s boyfriend and mother through posts on social media.
“We received confirmation that Ana Beatriz was approved and all the logistics are already being arranged for the medication to reach us”, said Vanessa Stubinski, the young woman’s mother.
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A few days ago, Vanessa had asked the authorities to evaluate the situation so that the situation could be dealt with.
According to family members, Ana Beatriz is admitted to the Hospital do Trabalhador without feeling or moving her legs.
“The Hospital do Trabalhador itself has already carried out the first application of this protein in Curitiba. Now I ask, from the bottom of my heart, that Ana Beatriz’s case be evaluated with the same opportunity”, pointed out the mother.
Eduardo, Ana’s partner, also published the confirmation on the networks: “Anvisa approved the application of polylaminin for Aninha”.
People close to me even republished the
Anvisa informed the CNN Brazil that the request in these cases must be made through compassionate use, either directly or via court, but to the sponsoring laboratory, in this case, Cristália.
Therefore, the laboratory must agree to donate the experimental medicine to the patient, instructing the patient with data that the patient’s case no longer has a therapeutic option, with evaluation and opinion from the responsible doctors and clinical history.
He also highlighted that he has made every effort to respond to requests quickly, within a maximum of 48 hours, with the response often coming within 24 hours.
Anvisa pointed out the clinical criteria that qualify a patient to receive unregistered medication, through compassionate use:
- Severity and stage of the disease;
- Lack of a satisfactory therapeutic alternative in the country for the clinical condition and its stages;
- Severity of the clinical condition and presence of comorbidities; and
- Assessment of the risk-benefit ratio of using the requested medication.
Doctor Tatiana
Polylaminin, developed by the Federal University of Rio de Janeiro (UFRJ), represents one of the most promising Brazilian initiatives in the area of neuroregeneration.
But there was controversy in the scientific community about the technical process of actually proving the result.
*Under the supervision of Thiago Félix
