Mallinck­rodt se­cures FDA ap­proval — but not with­out warn­ing; Rhythm seeks $100M af­ter reg­u­la­to­ry OKs

Mallinck­rodt just re­ceived an FDA thumbs-up.

The Amer­i­can-Irish phar­ma said Thurs­day that the reg­u­la­to­ry agency ap­proved its in­jec­tion ter­li­pressin, now mar­ket­ed as Ter­li­vaz for pa­tients with he­pa­tore­nal syn­drome, or HRS. Com­bined with rapid re­duc­tion in liv­er func­tion, the dis­ease oc­curs in pa­tients with ad­vanced stages of liv­er dis­ease and can be life-threat­en­ing.

The ap­proval was grant­ed af­ter a pos­i­tive Phase III read­out in 300 pa­tients with HRS, meet­ing the pri­ma­ry end­point of HRS re­ver­sal, but the drug comes with a boxed warn­ing of se­ri­ous or even fa­tal res­pi­ra­to­ry fail­ure.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER