FDA committee votes no on Mallinckrodt jaundice drug

May 04, 2018

NJ-based Mallinckrodt announced that an FDA advisory committee has voted against approval for the company's newly-acquired jaundice drug.

The Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee recommended in a vote of 21 to 3 that the risk-benefit profile of stannsoporfin does not support approval for the treatment of newborns ≥35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe jaundice.

Mallinckrodt bought the drug last year from InfaCare for $80 million upfront, hoping the drug would be a first-in-class pharmacologic treatment for severe jaundice in newborns with a novel mechanism of action that inhibits bilirubin production at its source.

Read the press release

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments