The US FDA Rejects Mallinckrodt's Terlipressin Due to Doubts in its Risk-Benefit Profile
Shots:
- The US FDA has issued CRL to Terlipressin’s NDA for the treatment of hepatorenal syndrome type 1 (HRS-1) and requires more information to support a positive risk-benefit profile for the therapy in HRS-1 patients
- The company is confident with its P-III CONFIRM study assessing the safety and efficacy of terlipressin in patients with HRS-1 for potential use in the US and Canada. On Jul 15- 2020- the FDA’s CRDAC voted to recommend approval of the therapy
- Terlipressin is a potent vasopressin analog selective for V1 receptors being evaluated for HRS-1 in the US and Canada and is approved in multiple countries outside the US
Ref: PRNewswire | Image: BioSpace
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