Novartis announced Monday the approval of a drug called Signifor for in all member states of the European Union as well as Norway and Iceland, designed to treat acromegaly patients who cannot undergo surgery, have undergone surgery without curative results, or have received inadequate treatment from first-generation somatostatin analogs.
In the EU, one to two individuals in every 10,000 is affected by acromegaly, with most cases featuring a non-cancerous tumor on the pituitary gland that leads to an overproduction of the growth hormone and insulin-like growth factor-1 in the body. High levels of GH and IGF-1 in the system lead to significant changes in the body physically, such as the enlargement of internal organs, facial features, feet and hands.
Additionally, cases where the acromegaly are not biochemically controlled lead to serious consequences in health like hypertension, heart disease, arthritis, diabetes, and colon cancer, which all lead to higher risks of death. According to research, up to 45 percent of cases are failing to normalize to levels of GH and IGF-1 using current treatment options. Signifor is made to target pituitary tumors directly, controlling acromegaly in instances where current somatostatin analogs are not helpful.
"Acromegaly that is not properly controlled can have a devastating impact on the long-term health of patients living with this serious pituitary disorder. 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." said Bruno Strigini, Novartis Oncology president.
The EU's approval was based on results from two multi-center Phase III studies. The studies C2402 and C2305 evaluated patients suffering from inadequately treated acromegaly or newly diagnosed patients where surgery didn't work, respectively. Both showed Signifor was highly effective in offering biochemical control as exhibited by measurements in levels of GH and IGF-1 in the bodies of patients.
This approval comes at the heel of a positive opinion the Committee for Medicinal Products for Human Use had in September about the drug as acromegaly treatment. Regulatory applications for Signifor have already been filed all over the world, including one in the United States.
Around the globe, acromegaly is most often seen in middle-aged men and women. It is a debilitating disease that is hard to detect because its development is gradual and it features symptoms that could easily be mistaken for a different condition. Because of the health complications acromegaly can cause, the condition is associated with up to a three-fold increase in deaths.
