Trick, or treat? FDA plans Halloween adcomm for Ipsen’s second chance at rare disease drug

An oft-maligned rare bone disease program at Ipsen is going to get a closer look from regulators on a day that’s proven to be mighty spooky.

The FDA has scheduled an advisory committee to examine Ipsen’s palovarotene on Oct. 31, according to a notice posted in the Federal Register, setting up a showdown for a drug that once failed a Phase III test. The hearing will come about two months ahead of palovarotene’s decision date, which is slated for Dec. 29.