The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting approval in the European Union (EU) for Roche’s PiaSky (crovalimab) to treat paroxysmal nocturnal haemoglobinuria (PNH), a rare, life-threatening blood condition.
PiaSky, a recycling monoclonal antibody that inhibits the complement protein C5, has been recommended for use in PNH patients aged 12 years and above weighing at least 40 kg. Patients may be new to or may have previously been treated with C5 inhibitors.
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If approved, it will become the first monthly subcutaneous treatment for PNH in the EU, offering self-administration after proper training.
A decision on the approval in the EU is anticipated soon.
The CHMP adopted a positive opinion for the asset’s approval based on data from the open-label, randomised Phase III COMMODORE 2 clinical trial.
The study assessed the safety and efficacy of PiaSky compared to eculizumab in PNH patients who had not previously been treated with C5 inhibitors.
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By GlobalDataTransfusion avoidance and control of haemolysis were the trial’s co-primary efficacy endpoints.
Results showed that PiaSky subcutaneous doses administered every four weeks were non-inferior to eculizumab, with comparable safety profiles and a similar rate of adverse events.
The treatment attained disease control and was found to be well-tolerated.
The application for approval also included data from two other Phase III studies: COMMODORE 1, involving patients switching from existing C5 inhibitors, and COMMODORE 3 in subjects new to C5 inhibitor treatment in China.
PiaSky has already been approved in the US, Japan and China as a monthly subcutaneous treatment for PNH, based on the COMMODORE studies.
Roche Global Product Development head and chief medical officer Levi Garraway said: “People living with PNH face lifelong treatment, often requiring frequent intravenous infusions and time-consuming clinic visits.
“With the option to self-administer once a month, the recommendation may therefore offer patients and caregivers in Europe more freedom in their day-to-day lives.”
In June 2024, the European Commission approved Roche’s Alecensa (alectinib) as the first adjuvant treatment for ALK-positive non-small cell lung cancer post-tumour resection with high recurrence risk.
