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 Approves Roche’s Established Antiviral For Children Aged Five Or Older
2022-08-12
In Response to Expanding Monkeypox Outbreak, FDA Approves Emergency Use of JYNNEOS Vaccine
2022-08-11
FDA Finds Carcinogen In Merck’s Diabetes Drug, Allows Continued Sales To Avoid Shortage
2022-08-11
LATEST
Vaccine Protecting Against 20 Different Pneumococcal Infections Proves Effective in Trial
2022-08-12
FDA Approves Roche’s Established Antiviral For Children Aged Five Or Older
2022-08-12
Novartis Reported Two Deaths Following Zolgensma Gene Therapy
2022-08-12
Extreme Climate Change Is Aggravating Infectious Diseases!
2022-08-11
In Response to Expanding Monkeypox Outbreak, FDA Approves Emergency Use of JYNNEOS Vaccine
2022-08-11
Potential $1 billion Acquisition of TeneoTwo by AstraZeneca comes to Fruition
2022-08-11
Gene Repair Therapy: First Patient Dosed With New Treatment for Sickle Cell Disease
2022-08-11
EVENT
2022-09-09
ESMO 2022 Exhibition
Online and on-side
2022-09-20
Cell & Gene Therapy USA 2022
Virtual
2022-09-21
RESI Boston
Boston
2022-09-21
CSCO Educational Book 2022
Xiamen
2022-09-26
Human Gene Therapy Conference
Australia
Scroll to Top

Create an account with us now to say goodbye to all the pop-ups!