Bristol-Myers Squibb has been told by the FDA that it must provide a further year of efficacy data to support its application for its developmental arthritis drug, Orencia.
In a document made public, the FDA acknowledges that Orencia therapy improves physical function over a 1-year timeframe in patients in patients with rheumatoid arthritis who have not been helped by disease modifying antirheumatic drugs, and a TNF blocker. However, the agency goes on to say that “obtaining a claim of improvement in physical function will require evidence that these benefits are sustained to two years.”
Bristol submitted to the FDA data from a 652 patient trial comparing Orencia plus methotrexate, with placebo plus methotrexate
In the trial 64% of Orencia patients achieved improvement in primary physical function on the “Health Assessment Questionnaire score” compared to 39% of placebo patients after one year of treatment.
The company is also seeking a claim that Orencia may be effective in combination with other drugs for arthritis.
Bristol has highlighted the drugs efficacy in patients refractory to anti-TNF agents (Abbott’s Humira, Amgen/Wyeth’s Enbrel and J&J’s Remicade) as a key avenue for growth.
The FDA accepts that Orencia is effective when used in tandem with these drugs, but the agency will need to discuss a slightly increased potential for infection with a scientific advisory committee.