LENMELDY
STN: 125758
Proper Name: atidarsagene autotemcel
Trade Name: LENMELDY
Manufacture: Orchard Therapeutics (Europe) Limited
Indication:
- Indicated for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile (PSEJ) or early symptomatic early juvenile (ESEJ) metachromatic leukodystrophy (MLD)
Product Information
- Package Insert - LENMELDY
- Demographic Subgroup Information – atidarsagene autotemcel (LENMELDY)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.