HORSHAM, Pa.—Johnson & Johnson subsidiaryJanssen Biotech Inc. suffered a setback to its plans for Simponi (golimumab)when the U.S. Food and Drug Administration rejected a new use for the drug,issuing a Complete Response letter for Janssen's supplemental Biologics LicenseApplication.
The application, which was filed in September2010, sought to expand the Simponi physician label to include inhibiting theprogression of structural damage, inducing major clinical response andmaintenance of reduction of signs and symptoms, and maintenance of improvedphysical function in the treatment of moderately to severely active rheumatoidarthritis.
The FDA had previously granted approval in April2009 to Simponi—when it was under the auspices of Centocor Ortho Biotech Inc.—forthe treatment of moderately to severely active rheumatoid arthritis, activepsoriatic arthritis and active ankylosing spondylitis—reportedly making thedrug the first patient-administered anti-tumor necrosis factor-alpha therapythat offered an effective once-monthly treatment option. The drug receivedsimilar approvals in Europe and Canada that same year.
Janssen leadership says the company intends torequest an end-of-review meeting with the FDA "to thoroughly understand thedetails of the Complete Response letter and discuss future steps to achieve theintended approval."
"Simponi is an important once-monthly anti-tumornecrosis factor-alpha therapy for rheumatologists in the treatment of patientswith moderately to severely active rheumatoid arthritis," says Dr. Jerome A.Boscia, Vice President and Head of Immunology Development in the CentocorResearch & Development division of Johnson & Johnson PharmaceuticalResearch & Development. "We look forward to collaborating with the FDA tofully understand the requirements needed to support this proposed labelexpansion."
The 2009 approvals for Simponi in treatingmoderately to severely active rheumatoid arthritis called for using it incombination with methotrexate. In January of this year, the European Commissionapproved the drug in combination with methotrexate for the treatment of adultswith severe, active and progressive rheumatoid arthritis not previously treatedwith methotrexate, and for the reduction in the rate of progression of jointdamage as measured by X-ray in patients with the disease. In early July, thedrug received Japanese approval for treating rheumatoid arthritis, includingprevention of articular structural damage in patients who showed inadequateresponse to conventional therapies.