Roche Holding AG (RHHBY) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended PiaSky as a monthly subcutaneous treatment for paroxysmal nocturnal hemoglobinuria (PNH) for patients aged 12 and above with a body weight of at least 40 kg. This recommendation applies to patients who are both new to treatment and those who have previously received C5 inhibitors.
If approved, PiaSky would become the first monthly subcutaneous treatment for PNH in the European Union, providing patients the option of self-administration as an alternative to existing C5 inhibitors. PNH is a rare, life-threatening blood disorder.
The CHMP's recommendation is based on the results of the Phase III COMMODORE 2 study, which demonstrated that PiaSky, administered via subcutaneous injections every four weeks, effectively controlled the disease and was well-tolerated.
PiaSky is already approved in the United States, Japan, and China for the treatment of PNH, following the results of the COMMODORE studies.
