Sobi’s Aspaveli obtains indication extension approval in Europe

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来源: Pharmaceutical Technology

Aspaveli, known as Empaveli in the US, is approved there for the treatment of adults with PNH. Credit: swiftsciencewriting from Pixabay.

Sobi has received approval for an indication extension from the European Commission for Aspaveli to treat adults with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia.

Uncontrolled complement activation in PNH, a chronic and life-threatening blood disorder, leads to the destruction of red blood cells that carry oxygen.

Aspaveli is approved in Europe to treat adult PNH patients who are anaemic following treatment with a C5 inhibitorC5 inhibitor for at least three months.

It is now the first C3 inhibitor approved for first-line PNH treatment in Europe, potentially improving patient outcomes by addressing haemoglobin levels and other clinical markers.

The approval for Aspaveli’s extended indication is based on data from the APL2-308 (PRINCE) study, an open-label, randomised, comparator-controlled trial.

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The study included patients who had not received any complement inhibitor treatment within three months before enrolment and exhibited haemoglobin levels below the normal lower limit and lactate dehydrogenase levels at least 1.5 times above the normal upper limit.

Over 26 weeks, the efficacy and safety of Aspaveli were assessed against standard care, which includes treatments such as transfusions and corticosteroids but excludes complement inhibitors.

Sobi chief medical officer and research and development and medical affairs head Lydia Abad-Franch stated: “Today’s approval underscores the robust clinical data supporting Aspaveli ‘s efficacy and safety profile, offering healthcare professionals and patients an expanded toolkit for effectively managing PNH.

“European patients will now be able to initiate treatment with Aspaveli at diagnosis or switch from their current C5 inhibitorC5 inhibitor treatment if they present indicators of haemolytic anaemia.”

Aspaveli, known as Empaveli in the US and commercialised by Apellis, is also approved there for the treatment of adults with PNH.

It is under investigation for the potential treatment of other rare diseases across the haematology and nephrology sectors.

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