IntraBio wins EC approval of Aqneursa
Texas, USA-based IntraBio revealed that the European Commission granted marketing authorization to Aqneursa (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick Type C (NPC) disease, following a positive opinion from the European Medicines Agency (EMA) human medicines committee, CHMP.
Aqneursa is approved in the European Union for use in adults and children aged 6 years and older weighing at least 20 kg. The approved indication includes use in combination with miglustat, or as monotherapy in patients where miglustat is not tolerated.
The Food and Drug Administration (FDA) approved Aqneursa for NPC last year. The FDA also approved Zevra Therapeutics’ (Nasdaq: ZVRA) Miplyffa (arimoclomol), in combination with miglustat, an enzyme inhibitor for this indication.
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