AbbVie To Proceed With Phase III Studies For ABT-494 In Rheumatoid Arthritis

AbbVie To Proceed With Phase III Studies For ABT-494 In Rheumatoid Arthritis

Global biopharmaceutical company, AbbVie, recently revealed plans to further develop its lead selective JAK1 inhibitor product candidate, ABT-494 in a Phase III clinical study on rheumatoid arthritis (RA). This step forward follows a recent report of ABT-494’s positive peformance in a pair of Phase II studies, evaluating the drug in RA patients with inadequate response to either methotrexate or TNF inhibitors. Despite a comprehensive review of the company’s available findings on the product, AbbVie will be foregoing its right to in-license Galapagos JAK1 inhibitor, filgotinib.

In the previously completed studies, ABT-494 was able to induce ACR20 at 12 weeks of treatment. “We believe ABT-494 has the potential to become a best-in-class therapy for patients,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “In our view, ABT-494 also offers a faster path to Phase 3 development with less uncertainty.”

Pursuant to the stipulations of the partnership between AbbVie and Galapagos, all rights to filgotinib will remain solely with Galapagos.

About Rheumatoid Arthritis

Rheumatoid arthritis is one of many autoimmune diseases in which the body attacks and damages its own connective tissue, leading to joint pain, stiffness, and arthritic changes in the joint. In up to thirty percent of cases, patients lose their ability to be gainfully employed after just 10 years post-diagnosis.

There are about 1.5 million Americans with rheumatoid arthritis and it is believed that the number of people with this condition is increasing. Women are more strongly affected than men and, while the peak incidence is between the ages of 40-70, rheumatoid arthritis can affect a person at any age.

Janssen Biotech, Inc. recently announced the US Food and Drug Administration has approved the company’s Supplemental Biologics License Application (sBLA) for SIMPONI ARIA (golimumab for infusion), a treatment of moderately to severely active rheumatoid arthritis (RA), to be evaluated according to measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36).

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