FDA rejects Ipsen rare-disease drug, more data and time needed to review
The FDA rejected Ipsen’s ultra-rare disease drug palovarotene, the company said, and has asked for more data from existing studies that will push another review out by more than six months.
The delay is the latest blow to the company’s attempts to get the drug approved in the US. In October, the agency postponed an advisory committee meeting to review the drug, saying that it needed more time to review data from the company that it had requested.
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