 Home > Active Ingredient News > Blood System > Aspaveli (pegcetacoplan) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), has received positive opinions from EU CHMP

Aspaveli (pegcetacoplan) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), has received positive opinions from EU CHMP

 Last Update: 2021-10-19
 Source: Internet
 Author: User

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Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, complex and acquired fatal blood disease.

Blood vessel

Apellis Pharmaceuticals announced today that the European Medicines Management Agency Committee medicines for human use (CHMP) has adopted a positive recommendation that Aspaveli (pegcetacoplan) listed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adult patients, these patients Anemia occurred after receiving C5 inhibitor treatment for at least three months

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Dr.

The positive opinion is based on the results of the head-to-head Phase III PEGASUS study, which evaluated the efficacy and safety of Aspaveli and eculizumab at 16 weeks

Thirty-five patients (85%) in the pegcetacoplan group no longer needed blood transfusions, and 6 patients (15%) who received eculizumab no longer needed blood transfusions

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