EMA — authorised 22 August 2024
- Application: EMEA/H/C/006061
- Marketing authorisation holder: Roche Registration GmbH
- Local brand name: Piasky
- Indication: Piasky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH): In patients with haemolysis with clinical symptom(s) indicative of high disease activity. In patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months.
- Status: approved
The EMA has approved Piasky, a treatment for paroxysmal nocturnal haemoglobinuria (PNH), a rare blood disorder. Piasky is indicated for use as monotherapy in adult and paediatric patients aged 12 and above, weighing at least 40 kg, with haemolysis and clinical symptoms indicative of high disease activity. It is also approved for use in patients who are clinically stable after being treated with a complement component 5 (C5) inhibitor for at least 6 months.