Regulatory, Setbacks

Jaundice drug for infants rejected by FDA, shaking up Mallinckrodt’s plans for newly-acquired stannsoporfin

It’s official. Mallinckrodt’s newly-acquired jaundice drug just got kicked back by the FDA.

The England-based drugmaker was expecting ominous news after the agency’s advisory committee voted strongly against the drug’s approval back in May. The company just bought the investigational med — called stannsoporfin — from InfaCare last year. It’s a heme oxygenase inhibitor designed to prevent jaundice in infants 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 paid $80 million upfront in a deal that could add up to $425 million if milestones were reached. 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 the drug is now on unstable ground.

The complete response letter (CRL) cited the need for additional data on newborns at least 35 weeks of gestational age.

“The letter from the FDA was not unexpected following the outcome at the recent Advisory Committee meeting,” said Steven Romano, Mallinckrodt’s executive vice president and CSO, in a statement. “We are evaluating the agency’s guidance and will request a meeting with the FDA in the coming months to discuss potential paths forward.”

Until that discussion, the company is not making a decision about the drug’s future, they said.

Mallinckrodt’s stock (NYSE: $MNK) is down 2.3% in pre-market trading Wednesday.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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