Mallinckrodt Completes NDA Submission For Kidney Failure Drug
Zacks Investment Research | Mar 18, 2020 08:50AM ET
Mallinckrodt plc (NYSE:MNK) announced that it has completed the rolling submission of the new drug application (“NDA”) seeking approval for its pipeline candidate, terlipressin, as a treatment for hepatorenal syndrome type 1 (HRS-1). The life-threatening syndrome involves acute kidney failure in cirrhosis patients. The company initiated the rolling submission last month. The company stated that the NDA submission is considered as a Class 2 resubmission.
Per the FDA guidelines, the review of a Class 2 resubmission is completed within six months of acceptance. The FDA’s acceptance of the terlipressin NDA is yet to be announced.
The NDA included data from the phase III CONFIRM study, which evaluated terlipressin in patients suffering the HRS-1 syndrome. The study was conducted by the company under FDA’s special protocol assessment. Data from the study presented at The Liver Meeting 2019 showed that treatment with terlipressin achieved the study’s primary endpoint of Verified HRS Reversal in statistically significant number of patients compared to placebo. The Verified HRS Reversal is defined as renal function improvement, avoidance of dialysis and short-term survival.
Terlipressin is not approved for any indication in the United States and Canada. However, it is approved for treating HRS-1 outside these two countries.
A potential approval to terlipressin in the United States will be encouraging for the company as the HRS-1 syndrome is estimated to affect 30,000-40,000 people every year. Moreover, there are no FDA-approved therapy and more than 80% of patients die, if not treated for three months. These factors suggest a significant unmet need in the targeted indication.
Shares of Mallinckrodt have lost 51.6% so far this year compared with the Zacks Investment Research
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