Pint Pharma and OrphanDC announced on July 25th that ANVISA, the National Health Surveillance Agency, approved, on July 25th, 2023, the drug EMPAVELI® (pegcetacoplan, indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)). Empaveli is the first treatment for PNH that binds to the complement protein C3.
PNH is a rare, chronic, and life-threatening blood disease in which uncontrolled complement activation leads to the destruction of red blood cells through intravascular hemolysis and extravascular hemolysis.
“The approval of Empaveli by ANVISA is a milestone for people living with PNH in Brazil, as PNH symptoms can significantly affect patients' quality of life,” said David Munoz, CEO and president of Pint Pharma.
According to Valnei Canutti, Hematologist and Chief of Scientific Affairs at Pint Pharma, “Pegcetacoplan is a therapeutic innovation for these patients, and with the arrival of Empaveli, we hope to contribute to the PNH community in Brazil effectively.”
"The approval of Empaveli is not only a victory for our company but mainly for the patients who will benefit from this innovative therapy," said Flavio Santoro, General Manager of Pint Pharma in Brazil.
