Bristol-Myers Squibb earlier this week received a unanimous nod from a US Food and Drug Administration advisory panel for its new rheumatoid arthritis agent, Orencia (abatacept)
A briefing paper issued prior to the meeting suggested that B-MS would be in for a mixed bag of news – with the panel expected to give its backing to the Orencia dossier but to ask it for an additional year of efficacy data before it would win approval for the drug’s physical function claim [[05/09/05b]].
Orencia is the first in a class of so-called T cell co-stimulation modulators that alter the way in which the body responds to inflammation, a key factor in RA. Although the decision on approvability came in ahead of expectations (the original action date was October 1 [[04/08/05e]]), the agency has requested an additional 90 additional days to complete its review of the Orencia file because of the complexity of the application.
In addition, B-MS says it plans to apply for a second manufacturing facility in order to meet expected long-term demand for the drug, but will only do so once it receives the thumb’s up from the FDA. In a statement, it said: “The company is currently determining what, if any, impact the delay [to the Orencia decision] could have on the timing of the sBLA approval [the manufacturing facility] and subsequent broad-scale commercial launch.”