Positive Phase III result for Mallinckrodt
UK-incorporated drugmaker Mallinckrodt (NYSE: MNK) has announced positive results from the Phase III CONFIRM study of terlipressin, in people with hepatorenal syndrome type 1 (HRS-1).
The study met its primary endpoint of Verified HRS Reversal (VHRSR), with 29.1 % of the test group achieving this outcome, compared with 15.8% of the placebo plus albumin group.
At present, there are no approved drug therapies for HRS-1 in the USA or in Canada. The firm plans to file for regulatory approval in the USA in the first half of 2020.
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