Roche’s PiaSky approved in the EU as first monthly subcutaneous treatment for people with PNH Page 1

• With the ability to self-administer, PiaSky (crovalimab) has the potential to reduce the treatment burden for people with paroxysmal nocturnal hemoglobinuria (PNH) in Europe and their caregivers
• The approval is based on COMMODORE 2, where once-monthly subcutaneous (SC) PiaSky was equivalent to every-two-weeks intravenous eculizumab^1,2
• PiaSky Improves C5 Inhibition through innovative recycling technology, which enables monthly SC administration³

Basel, August 27, 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, for adults and adolescents (12 years of age or older, weighing 40 kg and above) with paroxysmal nocturnal hemoglobinuria (PNH) who are new to or have previously been treated with C5 inhibitors. PNH is a rare and life-threatening blood disorder in which red blood cells are destroyed by the complement system – a part of the innate immune system – causing symptoms such as anemia, fatigue and blood clots, and potentially leading to kidney disease.⁴

“People with PNH are often burdened with lifelong, frequent intravenous infusions with time-consuming clinic visits, meaning their lives, as well as those of their caregivers and families, can revolve around the demands of their treatment,” said Prof. Alexander Röth, MD, head of Classical Hematology and Hemostasis at the West German Cancer Center, University Hospital Essen, Germany. “More flexible treatment options like PiaSky, which are just as effective but can be administered less frequently and more quickly at home, are essential to giving people with PNH more control over their treatment and greater independence.”

PiaSky is the first monthly subcutaneous (SC) treatment for PNH in the European Union, with the option to self-administer after adequate training. It offers an alternative option to current C5 inhibitors that require regular intravenous infusions, potentially helping to reduce the treatment burden and disruption to the lives of people with PNH and their caregivers.³

“The approval of PiaSky brings a new option to the PNH treatment landscape, combining the disease control achieved through C5 inhibition with an advanced recycling technology that enables monthly subcutaneous administration,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche. “We are excited to offer this new treatment to people with PNH in Europe, with the hope that it can help alleviate the treatment burden faced by many people with this condition.”

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