fbpx
Subscribe
Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors

Advertisment

Phase III LINC-4 study of Isturisa for the treatment of patients with Cushing’s disease.- Recordati

Written by | 18 Jun 2020 | Pharmacy

Recordati announces positive results from the large Phase III LINC-4 study of Isturisa (osilodrostat) for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

Data from the LINC-4 study demonstrate that a significantly higher proportion of patients receiving Isturisa achieve normal mUFC, the primary treatment goal for Cushing’s disease, after 12 weeks of treatment versus placebo (77% vs 8%; P<0.0001). Improvements in mUFC levels are sustained over 36 weeks of treatment(81% of patients). Isturisa is well tolerated and has a manageable safety profile, with the most common adverse events in LINC-4 being arthralgia, decreased appetite, fatigue, and nausea.

The findings from LINC-4, the first Phase III study of a medical therapy in Cushing’s disease to contain an upfront placebo-controlled phase, builds on existing clinical evidence and affirms the effectiveness of Isturisa in this hard-to-treat
patient population.

Isturisa has recently received marketing authorization in the European Union (January 2020) and United States (March 2020) for the treatment of Cushing’s syndrome and Cushing’s disease, respectively.

Newsletter Icon

Subscribe for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.

Subscribe

You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.