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GILEAD AND GALAPAGOS REPORT UPDATED SAFETY INFORMATION FOR FILGOTINIB IN RHEUMATOID ARTHRITIS (RA)

Nachrichtenquelle: GlobeNewswire
28.03.2019, 22:22  |  454   |   |   

  
-- Pooled Interim Phase 3 FINCH Program Data up to 24 Weeks and Phase 2b DARWIN 3 Long-Term Data Add to Evidence Supporting Filgotinib Safety Profile --

Foster City, Calif. and Mechelen, Belgium; March 28, 2019, 22.03 CET; regulated information - Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today also announced interim safety information from four studies of the investigational compound filgotinib for the treatment of rheumatoid arthritis (RA). The data include 24 week results of the ongoing Phase 3 FINCH 1, 2, and 3 trials, and updated Week 156 safety data from the Phase 2b DARWIN 3 long term extension study in patients with RA.

Week 24 safety data from the FINCH 1, 2, and 3 studies are aggregated and summarized in the table below. Data from 3,452 patients are reported, including 2,088 patients who received filgotinib.

  Placebo/
csDMARD
N= 1039
No. (%)
Adalimumab
+ MTX
40mg EOW
N=325
No. (%)
Filgotinib 100 mg +MTX/csDMARD
N=840
No. (%)
Filgotinib 200 mg +MTX/csDMARD
N=1038
No. (%)
Filgotinib 200 mg
N=210
No. (%)
Filgotinib Total
N=2088
No. (%)
Serious infections&  10 (1.0) 8 (2.5) 13 (1.5) 13 (1.3) 3 (1.4) 29 (1.4)
Herpes zoster& 4 (0.4) 2 (0.6) 5 (0.6) 6 (0.6) 1 (0.5) 12 (0.6)
DVT/PE& 3 (0.3) 0 (0) 0 (0) 1 (0.1)µ 0 (0) 1 (<0.1)
Death@ 2 (0.2) 0 (0) 1 (0.1) 3 (0.3) 0 (0) 4 (0.2)
Malignancy excluding NMSC& 4 (0.4) 1 (0.3) 1 (0.1) 0 (0) 0 (0) 1 (<0.1)
MACE& 5 (0.5) 1 (0.3) 2 (0.2) 2 (0.2) 1 (0.5) 5 (0.2)

MTX, methotrexate; EOW, every other week; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DVT, deep venous thrombosis; PE, pulmonary embolism; NMSC, non-melanoma skin cancer; MACE, major adverse cardiac events

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