CushieBlog

The FDA on Friday approved Recordati’s Isturisa (osilodrostat) to treat Cushing’s disease—a rare disease in which patients’ adrenal glands produce too much cortisol—in those who have undergone a prior pituitary gland surgery or are not eligible for one.

Isturisa, a cortisol synthesis inhibitor, will come with the FDA’s orphan drug designation, providing market exclusivity for seven years, Recordati said (PDF) in a release. The drug is expected to be commercially available in the second or third quarter.

The FDA based its review on phase 3 data showing 86% of patients treated with Isturisa showed normal cortisol levels in their urine after eight weeks, compared with 29% of patients treated with placebo, the drugmaker said.

Recordati is “actively building its commercial, medical, and market access teams” to accommodate Isturisa’s launch through its recently created U.S. endocrinology business unit, it said. The drugmaker will launch the drug with a “comprehensive distribution model” through specialty pharmacies.

Novartis, once the owner of Isturisa, turned the asset over to Recordati in 2019 as part of a $390 million offload of some of the Swiss drugmaker’s endocrinology portfolio.

Recordati received Signifor, long-acting sister Signifor LAR and Isturisa, positioned as a successor drug to Signifor. The purchase included milestone payments tied to Isturisa.

Recordati talked up the buy of the Cushing’s disease trio as a boon for its rare disease portfolio, calling it a “key and historical milestone” at the time.

From https://www.fiercepharma.com/pharma/recordati-scores-fda-nod-for-cushing-s-disease-med-isturisa