pe26 schreef op 5 februari 2018 23:09:
[...]
Super gevonden!
Gilead heeft 100% vertrouwen in Filgotinib = gelicenseerd Galapagos molecuul.
Hoeveel ziekte-indicaties in ontstekingsziekten: 11.
Dat worden er 13 (CGVHD + JIA).
CGVHD » BMT CTN 1602 studie
JIA » goedkeuring van EMA om Reumatische studies op te starten in kinderpatiënten. Zie onder besluit medio aug. 2017.
The Paediatric Committee (PDCO) adopted opinions agreeing paediatric investigation plans (PIPs) for the following medicines:
Filgotinib
Gilead Sciences International Ltd.; Treatment of chronic idiopathic arthritis (including
rheumatoid arthritis, ankylosing spondylarthritis, psoriatic arthritis, and juvenile idiopathic
arthritis)
Day 60 opinion
Immunology-Rheumatology-Transplantation
Summary of committee discussion:
The applicant provided the requested clarifications to the draft opinion in line with the
outcome of the Day 30 discussion. A positive opinion was adopted.