Novartis’ Isturisa (osilodrostat) Receives the US FDA’s Approval for Cushing’s Disease

 Novartis’ Isturisa (osilodrostat) Receives the US FDA’s Approval for Cushing’s Disease

Novartis, Isturisa, osilodrostat, Receives, US, FDA, Approval, Cushing’s Disease

Shots:

  • The approval is based on a study assessing Isturisa {starting dose of 2mg (bid) that could be increased q2w up to 30mg (bid)} in 137 adults with Cushing’s disease who either had undergone pituitary surgery that did not cure the disease or were not surgical candidates
  • The study resulted that half of the patients had cortisol levels within normal limits @24wks. Following the above study, 71 patients entered into 8wks. study assessing Isturisa vs PBO which resulted in maintenance of cortisol level (86% vs 30%)
  • Isturisa is the first FDA-approved therapy targeting the cortisol overproduction by blocking the enzyme k/a 11-beta-hydroxylase and preventing cortisol synthesis and has received FDA’s ODD for the same indication

Click here ­to­ read full press release/ article | Ref: FDA | Image: CNBC

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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