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Janssen seeks FDA approval of golimumab for ankylosing spondylitis, psoriatic arthritis
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Janssen Biotech Inc. announced it has submitted two FDA supplemental biologics license applications for golimumab in the treatment of ankylosing spondylitis and psoriatic arthritis, according to a press release.
“At Janssen, we are committed to addressing the unmet medical needs of patients living with psoriatic arthritis and ankylosing spondylitis through the discovery and development of innovative therapeutics,” Newman Yeilding, MD, head of immunology development at Janssen Research and Development, said in the release.
Golimumab (Simponi Aria, Janssen Biotech) — an anti-tumor necrosis factor therapy — is currently approved in combination with methotrexate for the 30-minute IV treatment of rheumatoid arthritis.
Two phase 3 studies — GO-ALIVE (ankylosing spondylitis) and GO-VIBRANT (psoriatic arthritis) — evaluated the efficacy and safety of the drug given as a 2 mg/kg IV infusion every 8 weeks after two starter doses at weeks 0 and 4. GO-ALIVE results were presented at the American College of Rheumatology 2016 Annual Meeting and GO-VIBRANT results will be presented at an upcoming meeting.
“We understand the need for additional treatment options for patients and their health care providers and hope to make Simponi Aria available for those in need,” Yeilding said.