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AbbVie Inc (ABBV) Submits Regulatory Applications to FDA and EMA for Upadacitinib
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G1 Therapeutics Announces Publication of Pooled Results from Pivotal Clinical Program of COSELA™ (trilaciclib) in Clinical Lung Cancer
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Harmony Biosciences Highlights Publication of WAKIX® (pitolisant) Efficacy Data in Sleep Medicine
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Second Phase 3 Induction Study Confirms Upadacitinib (RINVOQ™) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients
- 33 percent of patients achieved the primary endpoint of clinical remission (per Adapted Mayo Score) compared to 4 percent of patients treated with placebo at week 8 (p 0.001)[1]
- All ranked secondary endpoints were met[1]
- These results reaffirm findings from the first Phase 3 induction study, U-ACHIEVE[1,2]
- Safety results were consistent with the previous Phase 3 induction study and the known profile of upadacitinib, with no new safety risks observed[1-6]
- Upadacitinib, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as an oral therapy for moderate to severe ulcerative colitis and several other immune-mediated diseases[1,7-14]
Second Phase 3 Induction Study Confirms Upadacitinib ) Improved Clinical, Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients
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