July 19 2013 | By Márcio Barra
The FDA has approved an intravenous formulation of the tumor necrosis factor inhibitor Simponi Aria (golimumab)for the treatment of moderate to severe rheumatoid arthritis in combination with methotrexate, according to manufacturer Janssen Biotech. This makes it the fourth approval for the drug since its initial approval in 2009, making it a strong contender for blockbuster status. The drug is already approved for active psoriatic arthritis, active ankylosing spondylitis, and moderate to severe ulcerative colitis unresponsive to previous treatments, the latter back in May 2013.
The approval is supported by findings from the phase III Trial of Golimumab entitled GO-FURTHER, where Simponi Aria plus methotrexate was compared against placebo plus methotrexate. The active arm of the trial showed significantly improved signs and symptoms and physical function during the 52 weeks of the trial versus the placebo arm. The study’s primary endpoint was the proportion of patients with a 20% improvement in their ACR score (ACR20) at week 14, achieved by 58.5% of the patients in the active group compared with 24.9% of the patients in the placebo group.
Simponi Aria, or Golimumab, is an anti-TNF-alpha monoclonal antibody like J&J’s own Remicade and Abbvie’s Humira. Simponi aria is administered through infusion, and not through patient injection, like its predecessor Remicade. Because patient injection technique may vary, giving Simponi Aria in an infusion center ensures the patient is getting the proper dosage of the medicine. Other TNF blockers approved for the treatment of RA include Enbrel, from Amgen/Pfizer and Cimzia from UCB.For patients that do not respond to TNF inhibitors, other treatments available include Rituxan from Roche/ Biogen Idec, a B cell depletory; Orencia from Bristol-Myers Squibb, a T-cell inhibitor; and Actemra from Roche, an IL-6 inhibitor.
Simponi Aria was developed as a follow up to Remicade (infliximab), a monoclonal antibody approved in 1998, initially for Crohn’s disease and later for ulcerative colitis and rheumatoid arthritis. Last year Remicade brought J&J $6.1 billion. Simponi Aria is an expected blockbuster, having generated $607 million in sales in 2012, a figure that may double to $1.2 billion by 2016, according to estimates compiled by Bloomberg.
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