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