Janssen Biotech’s Simponi receives FDA approval for ulcerative colitis
The FDA has approved Janssen Biotech’s Simponi (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.
Simponi is the first and only subcutaneously administered anti-tumor necrosis factor (TNF)-alpha therapy approved to induce and maintain clinical response and improve endoscopic appearance of the mucosa during induction. In addition, Simponi is indicated to induce clinical remission and achieve and sustain clinical remission in induction responders.
For the treatment of UC, the Simponi dose regimen consists of 200mg subcutaneously injected at week 0, followed by 100mg at week two, then 100mg every four weeks thereafter.
The approval is supported by data from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) clinical trials, evaluating patients with moderately to severely active UC who had previously failed or were intolerant to conventional treatments. Significantly greater proportions of patients who received Simponi 200mg/100 mg achieved clinical response, clinical remission and improvement of the endoscopic appearance of the mucosa at week six compared with patients receiving placebo. Through week 54, significantly greater proportions of patients in the Simponi 100mg group maintained clinical response compared with the placebo group. The proportion of patients in clinical response following Simponi induction treatment who went on to demonstrate clinical remission at both weeks 30 and 54, without demonstrating a loss of response at any time point through week 54, were significantly greater in the Simponi 100mg group compared with the placebo group.
Simponi is also approved by the FDA for the treatment of moderately to severely active rheumatoid arthritis with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate and active ankylosing spondylitis.