(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to treat Cushing’s disease.
This new approval is found under the names Isturisa (osilodrostat) and is approved to treat adults.
Osilodrostat is an option for adults with Cushing’s disease who:
- Can’t have pituitary gland surgery
- Have had the surgery but still have Cushing’s disease
Cushing’s disease, affecting more women than men, typically occurs in people between 30 and 50 years old. This disease is rare. It happens when the adrenal glands make too much cortisol.
“The FDA supports the development of safe and effective treatments for rare diseases, and this new therapy can help people with Cushing’s disease, a rare condition where excessive cortisol production puts them at risk for other medical issues,” said Dr. Mary Thanh Hai, acting director of the FDA’s Office of Drug Evaluation II, in a press release.
Cushing’s disease can lead to serious health issues, such as high blood pressure, obesity, type 2 diabetes, and formation of blood clots in the legs and lungs. Other issues include bone loss that can lead to fractures. This condition can also lead to a weaker immune system.
Osilodrostat, available as a tablet, is taken twice a day.
The safety and effectiveness of osilodrostat was evaluated in a clinical trial. After the designated study period for this clinical trial, around half of patients saw cortisol levels within normal limits.
Common side effects of osilodrostat included headache, nausea and vomiting, feeling tired and edema (swelling).
The FDA granted this medication’s approval to Novartis.
Speak with your health care provider if you have any questions.