Steroidogenesis inhibitor

Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV® (levoketoconazole) for the Treatment of Cushing’s Syndrome

Retrieved on: 
Thursday, June 3, 2021

11,020,393 entitled, Methods of Treating Disease with Levoketoconazole which covers a method of treating Cushings syndrome patients with RECORLEV (levoketoconazole) who also take metformin for Type 2 diabetes.

Key Points: 
  • 11,020,393 entitled, Methods of Treating Disease with Levoketoconazole which covers a method of treating Cushings syndrome patients with RECORLEV (levoketoconazole) who also take metformin for Type 2 diabetes.
  • 9,918,984, covers methods of treating Cushings syndrome with levoketoconazole and will expire on January 10, 2026.
  • RECORLEV is an adrenal steroidogenesis inhibitor with a New Drug Application that is currently under review by the U.S. Food and Drug Administration for the treatment of endogenous Cushings syndrome.
  • RECORLEV has received orphan drug designation from the FDA and theEuropean Medicines Agencyfor the treatment of endogenous Cushing's syndrome.

Strongbridge Biopharma plc Announces Submission of New Drug Application for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome to the U.S. Food & Drug Administration

Retrieved on: 
Tuesday, March 2, 2021

The submission of the New Drug Application for RECORLEV (levoketoconazole) represents not only a significant milestone for Strongbridge but also for the Cushings syndrome community as a whole.

Key Points: 
  • The submission of the New Drug Application for RECORLEV (levoketoconazole) represents not only a significant milestone for Strongbridge but also for the Cushings syndrome community as a whole.
  • RECORLEV, the pure 2S,4R enantiomer of the enantiomeric pair comprising ketoconazole, is a next-generation steroidogenesis inhibitor being investigated as a chronic therapy for adults with endogenous Cushings syndrome.
  • RECORLEV has received orphan drug designation from the FDA and theEuropean Medicines Agencyfor the treatment of endogenousCushing'ssyndrome.
  • ET to discuss the Companys fourth quarter and full-year 2020 financial results and recent corporate highlights, including the RECORLEV NDA submission.

RECORDATI: ACQUISITION OF WORLDWIDE RIGHTS TO SIGNIFOR® AND OSILODROSTAT (LCI699) COMPLETED

Retrieved on: 
Wednesday, October 23, 2019

The acquisition also covers the worldwide rights to osilodrostat (LCI699), an investigational innovative drug for the treatment of endogenous Cushings syndrome, for which marketing authorization applications have been filed in the European Union and in the USA.

Key Points: 
  • The acquisition also covers the worldwide rights to osilodrostat (LCI699), an investigational innovative drug for the treatment of endogenous Cushings syndrome, for which marketing authorization applications have been filed in the European Union and in the USA.
  • Subsequently, additional milestone payments contingent upon the approval and market access of osilodrostat as well as royalties on sales of this new product, will be due.
  • Osilodrostat is an orally administered steroidogenesis inhibitor of 11Beta-hydroxylase, an enzyme which catalyses the final step of cortisol synthesis in the adrenal cortex.
  • Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.