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The US FDA Rejects Mallinckrodt's Terlipressin Due to Doubts in its Risk-Benefit Profile

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The US FDA Rejects Mallinckrodt's Terlipressin Due to Doubts in its Risk-Benefit Profile

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

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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