Shots:
- The US FDA has received sNDA of Aqneursa (levacetylleucine) for the treatment of Ataxia-Telangiectasia (A-T)
- sNDA was backed by the P-III trial assessing Aqneursa in adult and pediatric pts with A-T, which met its 1 & key 2EPs & showed that Aqneursa has a favorable safety profile
- Aqneursa was previously approved by both the US FDA & EMA for the treatment of neurological manifestations of Niemann-Pick disease type C in adults & pediatric pts (≥15kg)
Ref: Businesswire | Image: IntraBio | Press Release
Related News: IntraBio Reports Topline P-III (IB1001-303) Trial Data on Aqneursa for Ataxia-Telangiectasia
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