Module 9 2021

A little bit of future ... Ongoing MAA at EMA and beyond

Product

Disease area

Submisson date Holder

Autologous glioma tumor cells, inactivated Antineoplastic

10/01/2020

Epitopoietic Research Corporation-Belgium

Eladocagene exuparvovec

nervous system

01/28/2020 10/01/2020 05/21/2020

PTC therapeutics

Elivaldogene autotemcel

Adrenoleukodystrophy

Bluebird

Idecabtagene vicleucel

Multiple myeoloma

Bluebird/BMS

Lenadogene nolparvovec (LUMEVOQ)

Leber's hereditary optic neuropathy 10/29/2020

GenSight Juno Tpx

Lisocabtagene maraleucel

DLBCL

07/16/2020

Scott Gottlieb FDA Commissioner and Peter Marks (Jan 2019)

● By 2020 200 IND/year expected (800 active INDs) ● By 2025 10 -20 / year GTMPs approved based on current rates ● Review group expansion to add 50 additional reviewers

Novartis Pharma AG- Business use only- not for further distribution

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