Mallinckrodt to present 'late breaker' data on rare kidney complication

UK-headquartered Mallinckrodt (NYSE: MNK) today announced it will present results from its pivotal Phase III CONFIRM study in a late-breaker session on November 11 during The Liver Meeting 2019, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, USA.

The CONFIRM clinical trial assessed the efficacy and safety of terlipressin in 300 adults with hepatorenal syndrome type 1 (HRS-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis. CONFIRM is the largest prospective trial ever conducted in this patient population. Mallinckrodt announced in August that the study met its primary endpoint of verified HRS-1 reversal (p=0.012). "Verified HRS-1 reversal" is a term denoting three components: renal function improvement, avoidance of dialysis and short-term survival, said Mallinckrodt, whose shares gained nearly 2% to $2.59 in pre-market trading.

NDA filing planned for early 2020