Jazz’s development pipeline includes the clinical development of new therapies to treat unmet medical needs, line extensions for existing products, and the generation of additional clinical data for existing products.
1 Approved in the U.S. in August 2017 for the treatment of adults with newly-diagnosed t-AML or AML-MRC.
2 NDA submission assumes positive study outcome.
3 Expect to be ready to submit in mid-2018.
4 In 3Q17, the company entered into a collaboration and option agreement with ImmunoGen, Inc. under which the company will support ImmunoGen’s development of these investigational product candidates
5 IND submitted 3Q17; ImmunoGen expects to initiate a Phase 1 study by end of 2017.
6 Evaluation of deuterated oxybate continues as part of the once-nightly development process.
7 Evaluating early-stage product candidates, including recombinant pegaspargase.
t-AML = Therapy-Related Acute Myeloid Leukemia, AML-MRC = AML with Myelodysplasia-Related Changes, MAA = Marketing Authorization Application, ES = Excessive Sleepiness, OSA = Obstructive Sleep Apnea, NDA = New Drug Application, sNDA = Supplemental New Drug Application, VOD = Hepatic Veno-occlusive Disease, FPI = First Patient In, EDS = Excessive Daytime Sleepiness, GvHD = Graft versus Host Disease, ADC = Antibody-Drug Conjugate, ALL = Acute Lymphoblastic Leukemia