The European Commission has just approved a new drug that helps treat a rare hormonal disorder. The new drug is called Signifor and it was created by Novartis.
The new Signifor drug will be used to treat people who suffer from acromegaly, which cannot be removed surgically, experts say. The new Novartis drug Signifor was received approval after recent studies revealed that the drug can help keep the hormonal disorder in control better than any existing therapies.
Acromegaly is a hormonal disorder which is caused by a benign tumor found in the pituitary gland that secretes an excess growth hormone. This leads to the enlargement of body parts, like the hands, the feet or facial features.
Statistics reveal that one to two people per 10,000 have this disease in the European Union.
Signifor was approved by the European Commission as an acting release formulation to be used once a month as an intramuscular injection. The new drug is supposed to help patients suffering from acromegaly who cannot be operated on and are currently on treatments that do not show any results. Some of the patients suffering from acromegaly are being treated with a somatostatin analogue.
The approval of the new drug comes after two Phase 3 studies called C2402 and C2305. These two studies proved that Signifor has a superior efficacy and provides biochemical control over acromegaly, compared to the SSA drugs.
Novartis said the EU approval of the new Signifor drugs comes after a positive reaction by the Committee for Medicinal Products for Human Use in September 2014. The drug was approved for the treatment of acromegaly and it will apply to all 27 of the EU member countries, plus Norway and Iceland.