NVS Novartis AG (ADR)

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Drug Information

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Phase 3 trial to commence in 2017.
Ruxolitinib - REACH 3
Steroid-refractory chronic GVHD (Graft versus host disease)
Phase 3 trial to commence in 2017.
Ruxolitinib - REACH 2
Steroid-refractory acute GVHD (Graft versus host disease)
Phase 2 pivotal trial dosing initiation announced December 30, 2016.
Ruxolitinib - REACH 1
Steroid-refractory acute GVHD (Graft versus host disease)
Priority review granted February 22, 2017. PDUFA estimate for sNDA June 22, 2017 using 6-month timeline following receipt of sNDA.
Zykadia
First-line use in patients with ALK+ metastatic NSCLC
Phase 2 complete. Meeting planned with FDA early 2017 to discuss next steps.
SEG101
Sickle Cell Disease Pain Crises (SCPC)
Phase 3 data due 2Q 2017.
ACZ885 (canakinumab) - CANTOS
CV risk reduction
Phase 3 data released March 22, 2017 - primary endpoints not met.
RELAX-AHF-2 (RLX030)
Acute heart failure
Phase 3 data due 1H 2017.
RTH258 (brolucizumab)
Neovascular AMD
Phase 3 data due 2018.
QVM149
Asthma
Phase 3 data due 2019.
QAW039 (fevipiprant)
Asthma
Phase 3 data 1H 2018.
LEE011: MONALEESA-7
Breast cancer - (pre-menopausal)
Phase 3 data due 2019.
OMB157 (ofatumumab)
Relapsing multiple sclerosis
Phase 3 data due 2H 2017.
LEE011: MONALEESA-3
Breast cancer - (post-menopausal)
Phase 3 trial completion due 2018.
Entresto - PIONEER
In-hospital initiation vs. enalapril following ADHF (acute decompensated heart failure)
Phase 3 trial completion due 2018.
Entresto - TRANSITION
Pre- vs. postdischarge initiation following ADHF (acute decompensated heart failure)
Phase 3 interim analysis due 2018. Filing 2019.
Entresto - PARAGON
HF-pEF (heart failure with preserved ejection fraction)
Phase 3 trial completion due 2019. Filing 2020.
Entresto - PARADISE
AMI (acute myocardial infarction)
Phase 2 pivotal primary analysis due 2Q 2017. Interim analysis originally scheduled for 1Q 2017, now due at an upcoming meeting. Assume this meeting is EHA - June 22-25.
CTL019 - JULIET
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
BLA acceptance under priority review announced March 29, 2017. No PDUFA date given. Assume 6-month review - August 29, 2017.
CTL019
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
Phase 3 positive data released. Regulatory discussions ongoing.
BAF312
Secondary progressive multiple sclerosis
Phase 3 data due 2018.
AIN457 (Cosentyx)
Non-radiographic axial SpA
Phase 2/3 ongoing.
CNP 520
Alzheimer’s Disease
Phase 3 trial met primary endpoint September 2016. BLA filing due 2017
Erenumab
Migraine
Priority review granted November 14, 2016. PDUFA date estimate May 14, 2017.
Midostaurin (PKC412)
Acute myeloid leukemia (AML)
Priority review granted November 1, 2016. Approval announced March 13, 2017.
LEE011
HR+/HER2- advanced breast cancer
BLA filing 2017.
Adalimumab
Rheumatoid Arthritis