Health Boards
Janssen Biotech, Inc. announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of an investigational intravenous formulation of the anti-tumor necrosis factor (TNF)-alpha SIMPONI® (golimumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
“We are pleased to present the FDA with an application supporting the efficacy and safety of an intravenous formulation of SIMPONI seeking its approval for the treatment of moderately to severely active rheumatoid arthritis,” said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC. “Upon approval, an intravenous formulation of SIMPONI would offer rheumatologists and people affected by this chronic, immune-mediated inflammatory disease an important new treatment option, in addition to the currently available subcutaneous formulation of SIMPONI.”
The BLA is supported by findings from the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER) trial, which evaluated the safety and efficacy of intravenously administered SIMPONI, in combination with methotrexate, via a 30-minute infusion at weeks 0, 4 and then every eight weeks compared with placebo in 592 adults. Study participants had been diagnosed with active RA, defined as having at least six tender and six swollen joints, and had been receiving background methotrexate for at least three months.
The primary endpoint of GO-FURTHER is the proportion of patients demonstrating 20 percent improvement in arthritis signs and symptoms (ACR 20) at week 14. Secondary endpoints include a 50 percent improvement in arthritis signs and symptoms (ACR50) at week 24, improvements in disease activity and physical function, as measured by the European League Against Rheumatism (EULAR)/Disease Activity Score (DAS) 28-C-reactive protein (CRP) and Health Assessment Questionnaire (HAQ), and inhibition of structural damage, as measured by X-ray.
Week 24 signs and symptoms, physical function and safety results from the Janssen R&D-sponsored study were presented at the 2012 EULAR Annual Congress and the study appeared in the June 2012 Annals of the Rheumatic Diseases.
Long-term data, including signs and symptoms, structural damage and safety analyses, will be submitted for presentation at a medical congress in the future.
An application requesting approval of an intravenous formulation of SIMPONI for the treatment of moderately to severely active RA is currently under review in the European Union (EU).
Source: janssenbiotech.com
Simponi is currently taken by injection under the skin once a month to treat psoriasis and psoriatic arthritis.
“We are pleased to present the FDA with an application supporting the efficacy and safety of an intravenous formulation of SIMPONI seeking its approval for the treatment of moderately to severely active rheumatoid arthritis,” said Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC. “Upon approval, an intravenous formulation of SIMPONI would offer rheumatologists and people affected by this chronic, immune-mediated inflammatory disease an important new treatment option, in addition to the currently available subcutaneous formulation of SIMPONI.”
The BLA is supported by findings from the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER) trial, which evaluated the safety and efficacy of intravenously administered SIMPONI, in combination with methotrexate, via a 30-minute infusion at weeks 0, 4 and then every eight weeks compared with placebo in 592 adults. Study participants had been diagnosed with active RA, defined as having at least six tender and six swollen joints, and had been receiving background methotrexate for at least three months.
The primary endpoint of GO-FURTHER is the proportion of patients demonstrating 20 percent improvement in arthritis signs and symptoms (ACR 20) at week 14. Secondary endpoints include a 50 percent improvement in arthritis signs and symptoms (ACR50) at week 24, improvements in disease activity and physical function, as measured by the European League Against Rheumatism (EULAR)/Disease Activity Score (DAS) 28-C-reactive protein (CRP) and Health Assessment Questionnaire (HAQ), and inhibition of structural damage, as measured by X-ray.
Week 24 signs and symptoms, physical function and safety results from the Janssen R&D-sponsored study were presented at the 2012 EULAR Annual Congress and the study appeared in the June 2012 Annals of the Rheumatic Diseases.
Long-term data, including signs and symptoms, structural damage and safety analyses, will be submitted for presentation at a medical congress in the future.
An application requesting approval of an intravenous formulation of SIMPONI for the treatment of moderately to severely active RA is currently under review in the European Union (EU).
Source: janssenbiotech.com
Simponi is currently taken by injection under the skin once a month to treat psoriasis and psoriatic arthritis.