Roche: positive CHMP opinion for PiaSky in PNH

(CercleFinance.com) - Roche announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for its PiaSky in the treatment of paroxysmal nocturnal hemoglobinuria (PNH).


The CHMP has recommended PiaSky for use against this rare and potentially life-threatening blood disorder, in adults and adolescents (aged 12 or over and weighing 40 kg) who are new to or have previously been treated with C5 inhibitors.

The recommendation is based on the results of the COMMODORE 2 study, in which monthly PiaSky demonstrated disease control and safety equivalent to that of biweekly intravenous eculizumab.

A final decision on the approval of PiaSky is expected from the European Commission in the near future. If approved, it will be the first monthly subcutaneous treatment for HPN in the EU.


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