Janssen’s RA drug approved in US

Janssen Biotech’s rheumatoid arthritis treatment, Simponi Aria (golimumab), has been approved for use in combination with methotrexate in the United States by regulatory body, the FDA.

Simponi Aria has been approved for adults with moderately to severely active rheumatoid arthtitis, which affects approximately 1.3 Americans and over 23.5 million people worldwide. The drug is the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible therapy and has been shown to significantly improve signs, symptoms and physical function, as well as inhibit the progression of structural damage.

In phase 3 clinical trials, called GO-FURTHER, which evaluated golimumab in 592 moderately to severely active RA patients, results revealed that 59% of patients receiving treatment with Simponi Aria plus methotrexate experienced significant improvements in signs and symptoms at week 14, compared to only 25% of patients who received placebo plus methotrexate.

“SIMPONI ARIA demonstrated a compelling efficacy profile in the treatment of moderately to severely active rheumatoid arthritis in the GO-FURTHER study. The approval of SIMPONI ARIA represents our commitment to bringing forward new therapeutic options for patients living with immunological diseases, including potentially disabling diseases like rheumatoid arthritis.”

Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC.

“As leaders in rheumatology, we’re proud to expand our treatment portfolio by making an anti-TNF infusible medicine like SIMPONI ARIA available to patients. Treatment with SIMPONI ARIA provides a different infusion experience; patients can now receive this form of treatment administration with an anti-TNF therapy via a short infusion time of 30 minutes with a dosing regimen of every 8 weeks.”

Rob Bazemore, President, Janssen Biotech, Inc.

 

 

Related news:

FDA Approves Intravenous Golimumab (Simponi Aria) for Rheumatoid Arthritis (Medscape)

Reference links:

Janssen press release

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