GENE ONLINE|News &
Opinion
Blog

2022-07-29| Trials & Approvals

Applications for Medicine Treating Crohn’s Disease Submitted to EMA and FDA

by Max Heirich
Share To

AbbVie announced on July 27 that applications for their new medication, upadacitinib (RINVOQ®), have been submitted to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). The application’s foundation is top-line findings of three Phase 3 clinical trials testing the treatment for application in adults with moderate to severe Crohn’s Disease.

Related Article: Pfizer to Acquire Arena and its Immuno-Inflammatory Drug for $6.7 Billion

RINVOQ’s Effect on Crohn’s Disease

Crohn’s Disease is a type of inflammatory bowel disease that progressively worsens over time and might eventually worsen to the point where those suffering from it require urgent medical care, involving surgery in some cases. The symptoms can involve abdominal pain, diarrhea, weight loss, anemia, and fatigue, with potentially life-threatening complications.

Though the disease is lifelong, RINVOQ works to treat the symptoms caused by Crohn’s Disease. RINVOQ works to inhibit proteins from the Janus kinase (JAK) family, which helps regulate swelling. By inhibiting the protein, RINVOQ works to lessen the overactive immune response caused by Crohn’s Disease.

Applications Based on Positive Phase 3 Data

In total, there were three Phase 3 clinical trials to study the induction and maintenance of the treatment. U-EXCEED and U-EXCEL were induction studies designed to test the efficacy and safety of RINVOQ 45 mg once daily as induction therapy. At the same time, U-ENDURE did much the same, although on RINVOQ 15 mg and 30 mg once daily as maintenance therapy. All the studies were double-blind and placebo-controlled, conducted on adults with moderately to severely active Crohn’s disease.

All three studies achieved top-line results as patients treated with RINVOQ met the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance treatment.

These results are the foundation of AbbVie’s application to both the FDA and EMA.

Neil Gallagher, M.D., Ph.D., vice president, development, and chief medical officer at AbbVie, said in a statement, “Crohn’s disease can be debilitating and have a significant impact on a person’s daily life. Those patients still suffering fuel our continued commitment to innovation in care for patients with IBD, and we look forward to potentially introducing a new treatment option for this disruptive condition.”

Related Article: Finch’s First Microbial Cocktail Treating Clostridium Infection Registers Positive Results

©www.geneonline.com All rights reserved. Collaborate with us: service@geneonlineasia.com
Related Post
FDA Requests for a $7.2 Billion Budget in FY 2025 for Critical Health Initiatives
2024-03-12
Wegovy Expands Its Reach: First Weight-Loss Medication Approved to Reduce Cardiovascular Risk
2024-03-11
FDA Boxed Warning for CAR-T therapy, Affecting Bristol-Myers Squibb, Novartis, Janssen, Gilead Sciences
2024-01-24
LATEST
Innovative Cellular Mapping of BRCA-Related Breast Cancer Findings Reveals Novel Therapeutic Targets
2024-03-29
Previewing AACR 2024 With Select Pre-Meeting Highlights
2024-03-28
Roche Delivering on Malaria Screening Solutions for Blood Donation
2024-03-28
Innovating Cancer Treatment: The Role of ADC Technology at Nona Biosciences
2024-03-28
BIO CHINA 2024 Brings Biotech Experts and Industry Elites Together for Innovation
2024-03-27
Galderma’s Strong European IPO Debut
2024-03-26
Markets and Mergers: Boston Scientific and Axonics Shake Hands on Deal
2024-03-25
EVENT
2024-04-06
Biotech Innovation Funding Networking
Los Angeles, USA
Scroll to Top