Date: 2013-07-29
Type of information: Granting of a patent
Product name: Simponi®
Compound: golimumab
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Action mechanism: monoclonal antibody. Golimumab is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue.
Company: Janssen Biologics (J&J - USA)
Disease: ulcerative colitis (UC)
Latest news: * On September 23, 2013, Simponi® has received the European Commission approval for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.Simponi® is the first and only subcutaneous anti-tumor necrosis factor (TNF)-alpha treatment administered as an every-4-week maintenance therapy for UC. For patients with a body weight less than 80 kg, the drug is given subcutaneously as an initial dose of 200 mg, followed by 100 mg at week 2 and then 50 mg every 4 weeks thereafter. For patients with a body weight greater than or equal to 80 kg, Simponi® is given as an initial dose of 200 mg, followed by 100 mg at week 2 and then 100 mg every 4 weeks thereafter.Data from the clinical development Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT), which served as the basis for European Commission approval, showed that induction treatment with Simponi® induced clinical response, clinical remission, mucosal healing and improved quality of life as measured by the inflammatory bowel disease questionnaire (IBDQ) in patients with moderately to severely active UC. Further, per the European Commission-approved Summary of Product Characteristics, maintenance therapy with Simponi® maintained clinical response through week 54. In addition, in patients who had initially responded to induction therapy with Simponi®, more Simponi®-treated patients demonstrated sustained clinical remission and mucosal healing at weeks 30 and 54 compared with patients in the placebo group.* On 25 July 2013, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for Simponi®. The CHMP adopted a new indication as follows: ulcerative colitis (UC). Simponi® is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2013-09-23
Favourable opinion UE: 2013-07-25
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
