FDA approves Signifor® for the treatment of Cushing’s Disease

                                                        Signifor (pasireotide diaspartate) ,an orphan drug ,an analogue of somatostatin has been approved by the FDA for the treatment of Cushing’s disease on 14th Dec 2012. Signifor has been developed by Novartis.

                Cushing’s disease is a condition caused by pituitary adenoma ,which leads to overstimulation of adrenal glands and overproduction of cortisol. Leading to spectrum of signs symptoms including central obesity, buffalo hump,purple striae, altered diurnal variation, hyperglycemia,hypertension hirsutism and many more. There is one more entity called Cushing’s syndrome which has same range of signs and symptoms but caused due to other peripheral causes most commonly being iatrogenic i.e steroid administration.

           Usually Cushing's disease is due to pituitary adenoma or a small tumour which is removed surgically. In patients in whom it cannot removed surgically, Signifor can be given. It is a somatostatin analogue which acts mainly on somatostatin receptor 5. 

               ^{FDA approved Signifor based on the results of PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease).Results from the PASPORT-CUSHINGS study found that a decrease in mean urinary-free cortisol (UFC), the key measure of biochemical control of the disease, was sustained during the treatment period in most patients with a subset of patients reaching normal levels. The study also showed that certain clinical manifestations of Cushing's disease tended to improve.}

           ^{Signifor is given subcutaneously. The important side effects being hyperglycemia, diarrhea, nausea, abdominal pain, and gallstones.}

 

^{Source:http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332351.htm}