The company notes that Simponi Aria is the onlyfully-human anti-tumor necrosis factor (TNF)-alpha infusible therapy, and thatit has been shown to significantly improve signs and symptoms and physicalfunction, as well as inhibit the progression of structural damage due to RA. Some
1.3 million people in the United States, Janssennotes, are living with RA, which is a chronic, systemic inflammatory condition thatbrings with it such symptoms as pain, stiffness and inflammation and, in somecases, joint destruction and disability.
"Phase III data showed treatment with SimponiAria plus methotrexate significantly improved signs and symptoms and physicalfunction at week 24, and inhibited the progression of structural damage inpatients with moderate to severe RA at week 24 and 52," said Dr. SergioSchwartzman, a member of Janssen Biotech's advisory board and director of theInflammatory Arthritis Center at the Hospital for Special Surgery and an associateprofessor at Weill Cornell Medical College. "The approval of Simponi Ariaoffers rheumatologists a new anti-TNF infusible treatment for patients whodemonstrate an inadequate response to methotrexate; having treatment optionsremains critical for us to continue to meet the needs of our patients."
Market watchers have noted that the approval marks the biotech's continuing efforts to boost its rheumatology portfolio. That porfolio currently has the blockbuster drug Remicade at the forefront, but that monoclonal antibody therapeutic launched in 1998 and, while it is approved for a number of indications, including RA, it quite likely stands to face significant competition soon.
The approval is supported by findings from thePhase III GO-FURTHER trial (Trial of Golimumab, an Anti-TNF-alpha MonoclonalAntibody, Administered Intravenously, in Subjects with Active RheumatoidArthritis Despite Methotrexate Therapy), which evaluated 592 patients diagnosedwith moderately to severely active RA who had at least six tender and sixswollen joints at screening and baseline, had elevated C-reactive protein levelsat screening and who had been receiving background methotrexate for at leastthree months.
Results from the trial revealed 59 percent ofpatients receiving treatment with the Janssen Biotech drug plus methotrexateversus 25 percent of patients receiving placebo plus methotrexate experienced significant improvements in signsand symptoms at week 14, as demonstrated by at least 20 percent improvement inAmerican College of Rheumatology (ACR) criteria, the study's primary endpoint.A higher proportion of patients receiving Simponi Aria plus methotrexateachieved at least a 50 percent improvement in ACR criteria compared withpatients receiving placebo plus methotrexate at week 14.
"Simponi Aria demonstrated a compellingefficacy profile in the treatment of moderately to severely active rheumatoidarthritis in the GO-FURTHER study," said Dr. Jerome A. Boscia, vice presidentand head of immunology development for Janssen Research & Development, LLC."The approval of Simponi Aria represents our commitment to bringingforward new therapeutic options for patients living with immunologicaldiseases, including potentially disabling diseases like rheumatoidarthritis."
"As leaders in rheumatology, we're proud toexpand our treatment portfolio by making an anti-TNF infusible medicine like SimponiAria available to patients," said Rob Bazemore, president of JanssenBiotech. "Treatment with Simponi Aria provides a different infusionexperience; patients can now receive this form of treatment administration withan anti-TNF therapy via a short infusion time of 30 minutes with a dosingregimen of every 8 weeks."
