Novartis International announced on Monday that it has received approval from the European Commission for its drug called Signifor to treat a rare hormonal disorder called acromegaly.
Acromegaly is a syndrome caused by the pituitary glands' overproduction of growth hormones after puberty. It is a rare hormonal disorder in which children grow to abnormal heights and exaggerated bone structure, making them look like giants. Unfortunately, this disease cannot be prevented, so the only way to improve the patient's quality of life is by regulating the growth hormones through medications, surgery, or radiation.
The Swiss pharmaceutical company developed Signifor as a once-a-month medication for adults diagnosed with acromegaly and had previously received first-generation somatostatin analogue (SSA) or another hormonal treatment that regulates the pancreas and pituitary glands.
"Acromegaly that is not properly controlled can have a devastating impact on the long-term health of patients living with this serious pituitary disorder," said Bruno Strigini, President, Novartis Oncology, in a Marketwatch release. "This first approval of Signifor in acromegaly marks a much needed advance in the treatment of this rare disease and we are working hard to bring this therapy to this underserved patient population worldwide in the near future."
EU regulators based their approval on the results of a randomized clinical study involving 198 participants who have received SSA for the past six months. One group received a combined treatment of 40 mg and 60 mg of Signifor, while the other group received Sandostatin LAR or Somatuline Autogel.
The researchers observed that 15 to 20 percent of those who took Signifor showed reduction in their growth hormones compared to the other group who had zero during the first three months of medication. In addition, 80 percent of the Signifor showed reduction in tumor volume compared to 77 percent of the control group.
