In June, the Ministry of Health of the Russian Federation issued a registration certificate for Isturisa (osilodrostat), a drug manufactured by Recordati Rare Diseases (a subsidiary of the Italian pharmaceutical corporation Recordati). The drug is intended for the treatment of Cushing’s syndrome, a rare neuroendocrine disorder where the body produces too much cortisol. According to the state register, there are no other products with this active substance on the Russian market.
The development of osilodrostat was started by Novartis, which sold the rights to the investigational drug to Recordati in 2019. As part of that deal, Recordati also received pasireotide, a drug that had already been approved for use at that time.
Both drugs are used to treat Cushing’s disease. It is caused by the adrenal cortex hyperfunction and most often develops in people aged 20 to 45 years. If left untreated, Cushing’s syndrome causes serious life-threatening complications, icncluding heart or lung failure, renal hypertension, frequent bone fractures, and myopathy.
The US Food and Drug Administration (FDA) approved Isturisa in 2020, making it the first FDA-approved drug that directly inhibits the enzyme 11-beta-hydroxylase, crucial for cortisol synthesis in the adrenal glands. The drug has also received orphan status.
