Mallinckrodt jaundice drug snubbed by FDA advisory committee

Mallinckrodt got a big thumbs down from the FDA’s advisors who say data on the company’s newly-acquired jaundice drug isn’t convincing a majority of the group that it’s safe and effective.

The England-based drugmaker just bought the drug — called stannsoporfin — from InfaCare last year. It paid $80 million upfront in a deal that could add up to $425 million if milestones were reached. But the drug’s future is now cast in shadow, as the FDA’s advisory committee voted a strong no, with a clear majority (21 to 3) voting against an OK.

Stannsoporfin is a heme oxygenase inhibitor designed to prevent jaundice by turning down the dial on the formation of bilirubin, an orange-yellow pigment formed in the liver by the breakdown of hemoglobin and excreted bile.

Mallinckrodt was angling for an approval after InfaCare engineered a deal with the FDA to seek an approval based on a confirmatory Phase IIb study. But it looks like Mallinckrodt might have to add more data to the case for stannsoporfin before the drug moves forward.

The company released a statement Thursday evening.

“Mallinckrodt appreciates the committees’ review and discussion of stannsoporfin, and will work closely with the FDA as the review process continues. Given the outcome of today’s meeting, the company is evaluating alternatives for this development program.”

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