№ files_lp_4_process_3_057961
File format: docx Character count: 18723 File size: 3242 KB
Year: 2023
Study type: Randomized clinical trials
Drug investigated: GLPG2222
Combination therapy: With and without ivacaftor
Measured outcomes: Sweat chloride concentration, ppFEV1, FEV1 absolute changes
Study centers: Multiple international hospitals across Belgium, Netherlands, Serbia, Spain, United Kingdom, United States, Australia, Czech Republic, Germany, Ireland
Principal investigators: Scott C Bell, Peter J Barry, Kris De Boeck, Pavel Drevinek, J Stuart Elborn, Barry J Plant, Predag Minić, Eva Van Braeckel, Stijn Verhulst, Karine Muller, Desirée Kanters, Susan Bellaire, Herman de Kock, David E Geller, Katja Conrath, Olivier Van de Steen, Kors van der Ent
Participant groups: FLAMINGO (N=59), ALBATROSS (+ ivacaftor; N=37)
Safety population: Patients with cystic fibrosis and associated comorbidities
Data presentation: Supplementary figures and tables including waterfall plots and mean FEV1 changes
Price: 8 / 10 USD
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IVACAFTOR, Sachet containing granules 13.4 mg, Kalydeco®, Vertex Pharmaceuticals Pty Ltd
Year: 2025
Region / City: Australia
Topic: Cystic fibrosis treatment
Document Type: Submission for listing in Section 100, Highly Specialised Drugs Program
Organization: Vertex Pharmaceuticals Pty Ltd
Author: Vertex Pharmaceuticals Pty Ltd
Target Audience: Healthcare professionals, Medical practitioners
Effective Date: February 6, 2025
Date of Last Consideration: November 2023
Treatment Phase: Initial treatment, Continuing treatment
Indication: Cystic fibrosis
Population: Patients aged 1 to 4 months with specific mutations in CFTR gene
Clinical Criteria: Must be assessed through a cystic fibrosis clinic/center, G551D mutation or other gating mutations in CFTR gene
Prescription Type: Authority Required
Date of Submission: 5 October 2025
Modification Date: Not specified
Status: Registered
Listing Request Basis: Clinical need, equity
Background: Ivacaftor approved for treatment of CF
Context Description: A submission for listing a new strength of ivacaftor (13.4 mg granules) for cystic fibrosis patients aged 1 to 4 months with specific CFTR gene mutations, requesting inclusion in the Highly Specialised Drugs Program.
14th Global Albatross Self-Designed RoadmapAcademic Planning Roadmap for International Students (Form)
Year: 2024
Region / City: Sogang University
Theme: Academic Planning, Career Goals, International Students
Document Type: Roadmap, Academic Planning Form
Institution: Sogang University
Author: 김지영
Target Audience: International students at Sogang University
Period of Validity: 4 years (university study duration)
Approval Date: 2024
Date of Changes: N/A
Topics: GLPG2222 IVACAFTOR Albatross