AbbVie Inc

NYSE:ABBVUnited States

Jul 12, 2024

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• DJ AbbVie Seeks U.S., Europe OK of Rinvoq in Giant Cell Arteritis, from 9:01AM ET on Friday Jul 12, 2024 by Dow Jones

  9:01AM ET on Friday Jul 12, 2024 by Dow Jones
  Companies Mentioned: ABBV
  
  By Colin Kellaher
  
  AbbVie has filed for expanded U.S. and European approval of its blockbuster autoimmune drug Rinvoq for the treatment of adults with giant cell arteritis, an inflammatory disease that can cause headache, jaw pain and changes in vision, including sudden and permanent vision loss.
  

• AbbVie Submits FDA, EMA Applications for Upadacitinib to Treat Giant Cell Arteritis, from 8:55AM ET on Friday Jul 12, 2024 by MT Newswires

  8:55AM ET on Friday Jul 12, 2024 by MT Newswires
  Companies Mentioned: ABBV
  08:55 AM EDT, 07/12/2024 (MT Newswires) -- AbbVie (ABBV) said Friday that it has submitted new indication applications to the US Food and Drug Administration and the European Medicines Agency for its drug upadacitinib for the treatment of adult pati...

• AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ(R)) in Giant Cell Arteritis, from 8:30AM ET on Friday Jul 12, 2024 by Dow Jones

  8:30AM ET on Friday Jul 12, 2024 by Dow Jones
  Companies Mentioned: ABBV
  
  REFERENCES
  1. AbbVie. Data on file ABVRRTI78418. 2. Ameer MA, Peterfy RJ, Khazaeni B. Giant cell arteritis. Updated August 8, 2023. https://www.ncbi.nlm.nih.gov/books/NBK459376/ 3. Weyand CM, Goronzy JJ. Immunology of Giant Cell Arteritis. Circ Res. 2023;132(2):238-250. doi:10.1161/CIRCRESAHA.122.322128 4. Giant Cell Arteritis. Arthritis Foundation. Available at: https://www.arthritis.org/diseases/giant-cell-arteritis. Accessed April 11, 2024. 5. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2024. 6. Pipeline -- Our Science | AbbVie. 2023. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed April 17, 2024. 7. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants with Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed April 9, 2024 8. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants with Takaysu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04161898. Accessed April 9, 2024. 9. Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05843643. Accessed April 9, 2024. 10. A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy (Step-Up HS). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT05889182. Accessed April 9, 2024. 11. A Study To Assess Adverse Events and Effectiveness of Upadacitinib Oral Tablets in Adult and Adolescent Participants With Vitiligo (Viti-Up). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06118411. Accessed April 9, 2024. 12. A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata (Up-AA). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06012240. Accessed April 9, 2024.