Roche: Brussels approves HPN drug

(CercleFinance.com) - Roche reports that the European Commission has approved its PiaSky for adults and adolescents (aged 12 or over and weighing 40 kg or more) with paroxysmal nocturnal hemoglobinuria (PNH).


PNH is a rare and potentially fatal blood disorder in which red blood cells are destroyed by the complement system, causing symptoms such as anemia, fatigue and blood clots, and potentially leading to kidney disease.

As the first monthly subcutaneous (SC) treatment for HPN in the EU, with the option of self-administration after appropriate training, PiaSky provides an alternative option to current C5 inhibitors which require regular intravenous infusions.

This approval is based on the Phase III COMMODORE 2 study in HPN patients, which demonstrated that PiaSky, administered as SC injections every four weeks, controlled the disease and was well tolerated.


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