FDA raises questions about Mallinckrodt's HRS-1 drug before advisory hearing

Last August, UK drugmaker Mallinckrodt presented positive topline findings for its embattled terlipressin, illustrating the candidate met its primary endpoint in treating a life-threatening form of liver disease that causes kidney failure.

But the FDA continues to have questions about terlipressin’s safety and efficacy. After determining from the outset of the trial that the primary endpoint would only classify as a surrogate endpoint, the agency is questioning whether or not patients “trended toward clinical improvements” while on terlipressin. Regulators will convene in a hearing today and have released a document outlining their thinking ahead of the meeting.