Novartis’ Isturisa (osilodrostat) leads recent innovation in Cushing’s disease (CD) with its latest Food and Drug Administration (FDA) approval, says GlobalData, a leading data and analytics company.
Isturisa, an 11-beta-hydroxylase inhibitor, is the first FDA approved drug to directly target overproduction of cortisol, the hormone of issue in CD. The drug has proven to be successful in clinical trials, with the Phase III LINC-3 trial showing impressive cortisol normalization in 50% of CD patients, and an even more promising cortisol level maintenance of 86% compared to 30% seen in placebo-treated CD patients, after 24 weeks.
Heather Farrell, MPharm, Pharma Analyst at GlobalData, says: “Cushing’s Disease has limited approved therapies, as the main treatment is generally surgical intervention. Unfortunately, up to 25% of patients will suffer from recurrence of the disease, leaving drug therapy as their only option to manage the disease.
“Many clinicians use drugs off-label and thus an approval in this indication is paramount to future patient outcomes. Patients will benefit from a reduction in further complications such as hypertension and risk of diabetes, placing a greater burden on their lives and healthcare systems. Isturisa has shown strong trial results and most importantly the ability to maintain the cortisol level at a normal range, increasing quality of life for patients. Already approved by the EMA, this FDA approval will bring greater access to patients and impact greatly on the Recordati sales of the drug.”
The approval of Isturisa is positive news for Recordati, however, another CD drug has completed positive phase III trials. Strongbridge’s Recorlev (levoketoconazole), a steroidogenesis inhibitor has had strong trial results in reducing cortisol and maintaining this normal level of cortisol in the body. The two drugs will compete for market lead, however Isturisa’s head start and prior EMA approval will be advantageous.
As many CD treatments lack complete efficacy, many are used in a combination regimen. Isturisa is similar to Metopirone (metyrapone) in mechanism, one of the most common treatments in CD. Isturisa will aim to take a large portion of Metopirone’s patient share as it has shown greater efficacy with less frequent dosing intervals. Therefore, not only will Isturisa be able to overtake this patient share, but as combination trials take place, there will be further opportunities to increase patient share.
Farrell concludes: “As the first FDA approved drug that directly tackles abnormal cortisol levels, CD patients are now seeing the innovation and developments in therapies they need to improve quality of life and disease state.”