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Details:
Based on enzymatic and cellular assays, RINVOQ (upadacitinib) demonstrated greater inhibitory potency for JAK-1 vs. JAK-2, JAK-3 and TYK-2. The safety results of upadacitinib were generally consistent with the known safety profile, and no new safety risks observed.
Lead Product(s):
Upadacitinib
Therapeutic Area: Gastroenterology
Product Name: Rinvoq
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 29, 2022
Details:
First and only investigational Phase 3 trial to show positive results in these young children; results follow recent approval of Dupixent (Dupilumab) in people with eosinophilic esophagitis aged 12 years and older who weigh at least 40 kilograms.
Lead Product(s):
Dupilumab
Therapeutic Area: Gastroenterology
Product Name: Dupixent
Highest Development Status: Phase III
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Regeneron Pharmaceuticals
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
July 14, 2022
Details:
Data from three studies publication reports the efficacy and safety results of two induction studies and a maintenance study evaluating clinical remission and endoscopic improvement with oral Rinvoq (upadacitinib) versus placebo over 8 weeks and 52 weeks.
Lead Product(s):
Upadacitinib
Therapeutic Area: Gastroenterology
Product Name: Rinvoq
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 27, 2022
Details:
SKYRIZI (Risankizumab) is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including Crohn's disease.
Lead Product(s):
Risankizumab
Therapeutic Area: Gastroenterology
Product Name: Skyrizi
Highest Development Status: Phase III
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 27, 2022
Details:
RINVOQ is selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.15-20 In human cellular assays, upadacitinib inhibits signalling by JAK1 or JAK1/3.
Lead Product(s):
Upadacitinib
Therapeutic Area: Gastroenterology
Product Name: Rinvoq
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 23, 2022
Details:
In patients with Crohn's disease who achieved clinical response showed, a significantly greater proportion treated with either upadacitinib achieved clinical remission, a,b endoscopic response, and endoscopic remission at week 52 compared to placebo.
Lead Product(s):
Upadacitinib
Therapeutic Area: Gastroenterology
Product Name: Rinvoq
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
May 11, 2022
Details:
Dupixent 300 mg weekly, a fully human mAB that inhibits signaling of interleukin-4 and interleukin-13 pathways, significantly improved signs and symptoms of EoE at 24 weeks compared to placebo, including ability to swallow and reduction in eosinophil count in esophagus.
Lead Product(s):
Dupilumab
Therapeutic Area: Gastroenterology
Product Name: Dupixent
Highest Development Status: Phase III
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Regeneron Pharmaceuticals
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
April 04, 2022
Details:
The FDA has extended PDUFA action date by three months to review additional data submitted by AbbVie for SKYRIZI (risankizumab-rzaa) for the treatment of moderate to severe Crohn's disease in patients 16 years and older.
Lead Product(s):
Risankizumab-rzaa
Therapeutic Area: Gastroenterology
Product Name: Skyrizi
Highest Development Status: Phase III
Product Type: Large molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 28, 2022
Details:
Consistent with results from the U-EXCEED induction study, higher proportion of patients receiving upadacitinib 45 mg also achieved steroid-free clinical remissiond per CDAI and per SF/AP compared to placebo at week 12 among patients taking corticosteroids at baseline.
Lead Product(s):
Upadacitinib
Therapeutic Area: Gastroenterology
Product Name: Rinvoq
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
February 24, 2022
Details:
Rinvoq (Upadacitinib), selective and reversible JAK inhibitor achieved both primary endpoints of clinical remission and endoscopic response at week 12 in adults with moderate to severe Crohn's disease.
Lead Product(s):
Upadacitinib
Therapeutic Area: Gastroenterology
Product Name: Rinvoq
Highest Development Status: Phase III
Product Type: Small molecule
Partner/Sponsor/Collaborator:
Not Applicable
Deal Size: Not Applicable
Upfront Cash: Not Applicable
Deal Type: Not Applicable
December 06, 2021
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