FDA AC to consider Abatacept for RA today
See the FDA briefing document for today’s meeting of the FDA Arthritis Drugs Advisory Committee. Bristol-Myer’s briefing document is also available from the FDA website. If you read the FDA BD, make sure to download the errata as well. The abatacept meeting is one of two very important meetings for BMS this week; Pargluva will be reviewed by the Endocrine and Metabolic AC Friday. Overall, FDA’s briefing doc for Abatacept suggests that they will endorse approval for all proposed indications, including physical function improvement, although they noted deficiency of two-year data for this indication in one of the pivotal studies. The most important saftey concern is malignancy, especially lung cancer and lymphoma. BMS has proposed pharmacoepidemiologic studies post-approval to address this. The safety/risk-management discussion surrounding Abatacept will give observers a better idea of FDA’s current attitudes towards post-marketing investigations of safety in the post-Vioxx era. Liability concerns have not prevented BMS from seeking to investigate uncommon safety signals in the post-marketing setting. Presumably, however, BMS will be willing (if not eager) to accept prominent label warnings of potential malignancy and infection risk until such studies have been completed.
