EU Approval Recommended for Roche’s PiaSky in PNH Treatment

Roche’s PiaSky Receives Positive CHMP Opinion for PNH Treatment in EU

Today, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended PiaSky® (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). PiaSky, a novel recycling monoclonal antibody that inhibits the complement protein C5, is recommended for use in adults and adolescents (12 years of age or older and weighing 40 kg or more) who are either new to or have previously been treated with C5 inhibitors.

If approved, PiaSky will become the first monthly subcutaneous treatment option for PNH in the European Union, offering patients the possibility of self-administration following proper training. This could potentially reduce treatment burden compared to current intravenous infusion therapies.

Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, highlighted the potential impact of this recommendation on patients’ lives, providing more flexibility and convenience in managing their condition.

PNH is a rare, life-threatening blood disorder affecting about 20,000 individuals worldwide, characterized by the destruction of red blood cells through the complement system. PiaSky, which can be administered subcutaneously every four weeks following an initial phase, has shown efficacy and safety comparable to existing intravenous treatments in clinical trials.

The CHMP’s recommendation is based on data from the Phase III COMMODORE 2 study, demonstrating PiaSky’s ability to control PNH symptoms effectively while being well-tolerated. Pending final approval by the European Commission, this recommendation marks a significant advancement in treatment options for PNH patients in Europe.

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