Isturisa Now Available in France, Recordati Announces

Cushing’s syndrome treatment Isturisa (osilodrostat) now is commercially available in France.

The announcement from Recordati Rare Diseases comes soon after the medication became fully available for sale and distribution to adults in the U.S.

The company stated that the medication will be made available elsewhere in the European Union later this year. In order to allow clinicians greater flexibility for individualized patient treatment, three dosages (1, 5, and 10 mg tablets) are being made available.

“Isturisa is a meaningful addition to the treatment options for Cushing’s syndrome and helps address the unmet need of patients,” Jacques Young, MD, PhD, said in a press release. Young is a professor at University of Paris-Saclay and an investigator in clinical trials of the medication.

Isturisa was approved by the European Commission as a treatment for people with endogenous Cushing’s syndrome earlier this year. Recordati recently acquired the marketing rights for the therapy from original developer Novartis.

Isturisa works by blocking the activity of an enzyme called 11-beta-hydroxylase. This enzyme is necessary for the production of the hormone cortisol; high levels of cortisol are the defining feature of Cushing’s syndrome.

The EC’s approval of Isturisa was based on data from the LINC-3 Phase 3 clinical trial (NCT02180217), which enrolled 137 people with Cushing’s. Participants all were given Isturisa initially; then, some participants — those who had achieved normal cortisol levels — continued on Isturisa, while others were given a placebo, for eight weeks.

Compared to those switched to placebo, significantly more participants who stayed on the therapy had normal levels of cortisol in their urine after this eight-week-long randomization period (86% vs 29%).

The most common side effects of Isturisa were adrenal insufficiency, fatigue, nausea, headache, and edema.

“[Isturisa] is supported by data generated through prospective clinical trials within the development program of Isturisa, providing robust evidence in terms of helping patients to achieve normal cortisol levels while also improving clinical signs and symptoms and their quality of life,” Young said.

“We had the opportunity to benefit from Isturisa as part of a special access scheme in France since April 2019. Response to the treatment has been extremely positive across the severity spectrum of Cushing’s patients, even more so when I consider my patients that have switched from current treatment options,” he added.