SOUTH SAN FRANCISCO (dpa-AFX) - Roche Holding AG (RHHBY) announced today
that the EMA's Committee for Medicinal Products for Human Use or CHMP
recommended PiaSky as a monthly subcutaneous treatment for paroxysmal nocturnal
haemoglobinuria or PNH for patients aged 12 and above, with a weight of 40 kg,
who are new to or have received previous treatment with C5 inhibitors.

Roche said, if approved, PiaSky will become the first monthly subcutaneous
treatment for PNH in the European Union, offering the option of
self-administration as an alternative to current C5 inhibitors. PNH is a rare,
life-threatening blood condition.

The CHMP's recommendation stems from the findings of the Phase III COMMODORE 2
study, which showed that PiaSky, given as SC injections every four weeks,
controlled the disease and was well-tolerated.

The PiaSky as a monthly subcutaneous treatment is already sanctioned in the US,
Japan, and China for individuals with PNH based on the results of the COMMODORE
studies.



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