NDAORALGRANULEPriority Review
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7
Mechanism of Action
Chloride Channel Activation Potentiators
Pharmacologic Class:
Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Clinical Trials (5)
Orkambi Treatment in 2 to 5 Year Old Children With CF
Started Apr 2019
28 enrolled
Cystic Fibrosis
Gastrointestinal Study at Orkambi Therapy in CF Patients
Started Feb 2019
20 enrolled
Cystic Fibrosis
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
Started Sep 2018
61 enrolled
Cystic Fibrosis
Impact of the Introduction of ORKAMBI on Anxiety, Depression, Quality of Life and Adherence of Adolescents and Young Adults
Started Dec 2017
Cystic Fibrosis
GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis
Started Nov 2017
22 enrolled
Cystic Fibrosis
Loss of Exclusivity
LOE Date
Jun 11, 2031
64 months away
Patent Expiry
Jun 11, 2031
Exclusivity Expiry
Mar 2, 2030