Isturisa

osilodrostat

Opinion

On 14 November 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Isturisa1, intended for the treatment of Cushing’s syndrome. The applicant for this medicinal product is Novartis Europharm Limited.

Isturisa will be available as 1-mg, 5-mg and 10-mg film-coated tablets. The active substance of Isturisa is osilodrostat, a cortisol synthesis inhibitor (ATC code: H02CA02). Osilodrostat works by inhibiting 11-beta-hydroxylase (CYP11B1), an enzyme responsible for the final step of cortisol biosynthesis in the adrenal gland.

The benefits with Isturisa are its ability to control or normalise raised cortisol levels. The most common side effects are gastrointestinal disorders, fatigue, headache, oedema and, as the most serious common side effect, adrenal insufficiency.

The full indication is: “Isturisa is indicated for the treatment of endogenous Cushing’s syndrome in adults”. It is proposed that Isturisa be initiated and supervised by physicians experienced in endocrinology or internal medicine and with access to the appropriate facilities for monitoring of biochemical responses.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1 This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

Key facts

Name
Isturisa
Agency product number
EMEA/H/C/004821
International non-proprietary name (INN) or common name
  • osilodrostat
Active substance
  • Osilodrostat phosphate
Therapeutic area
Cushing Syndrome
Date opinion adopted
14/11/2019
Company name
Novartis Europharm Limited 
Status
Positive
Application type
Initial authorisation

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