Johnson & Johnson (J&J) can now offer rheumatoid arthritis (RA) patients in the US an alternative to its subcutaneous version of Simponi after regulators approved the intravenous version Simponi Aria.
The Food and Drug Administration (FDA) said that J&J should be allowed to market Simponi Aria (golimumab) for infusion to treat adults with moderately to severely active RA through an intravenous infusion at weeks 0 and 4, then every 8 weeks after that.
This will be welcome news for some patients currently taking the self-injectable version, which is approved to be dosed every 4 weeks in the treatment of RA.
As with the subcutaneous approval, the intravenous recommendation covers the drug’s use in combination with methotrexat.
J&J explained that the approval was based on phase III data that demonstrated Simponi Aria plus methotrexate significantly improved signs and symptoms and physical function in RA patients after 24 weeks of treatment.
“Treatment with Simponi Aria provides a different infusion experience; patients can now receive this form of treatment administration with an anti- tumour necrosis factor (TNF) therapy via a short infusion time of 30 minutes with a dosing regimen of every 8 weeks,” said Rob Bazemore, president of Janssen Biotech – the J&J subsidiary responsible for marketing Simponi Aria.
The approval means that J&J owns the first anti-TNF therapy available via infusion in more than a decade, although the class is still dominated by AbbVie’s Humira (adalimumab), which managed worldwide sales of more than $9bn during 2012.
By contrast, Simponi made just $607m in the same period for its existing indications in RA, psoriatic arthritis and active ankylosing spondylitis.
These results should be improved following the intravenous approval and a May 2013 FDA approval for use in ulcerative colitis, with Bloomberg reporting analysts’ estimates that Simponi could be on course for annual sales of $1.2bn by 2016.
This article was updated on July 24 to clarify Simponi Aria is the first anti-TNF therapy available via infusion for patients with RA in more than a decade