Anvisa authorizes experimental drug for influencer Lito Sousa

Anvisa has authorized the exceptional import and use of the experimental drug ALN-6457 for Lito Sousa, a prominent aviation influencer diagnosed with Creutzfeldt-Jakob disease (CJD). The medication, developed by Regeneron Pharmaceuticals, is currently in a pre-clinical stage and has not yet undergone formal human clinical trials for this specific prion disease.

The authorization was granted under compassionate use regulations, as the disease is characterized by rapid, lethal, and irreversible neurodegeneration. The request was facilitated by the Hospital Israelita Albert Einstein. Because the drug lacks a commercial registration or legal representative in Brazil, the process required coordination between Anvisa, the Brazilian Ministry of Health, and the U.S. Food and Drug Administration (FDA).

Lito Sousa, who has recently been managing his condition at home with intensive palliative care, reported that while his physical mobility is limited, his cognitive functions remain intact. His wife, Mila Seidl, noted that the medication is expected to arrive in Brazil within seven to nine days. She emphasized that the approval followed established legal protocols for rare diseases rather than being a unique privilege.