ROCKVILLE, Md. -- The FDA has approved lanreotide acetate (Somatuline) for the treatment of the rare endocrine disorder acromegaly.
ROCKVILLE, Md., Aug. 31 -- The FDA has approved lanreotide (Somatuline) for the treatment of the rare endocrine disorder acromegaly.
The drug, already marketed in 60 countries, was given orphan drug status, the FDA said, and is indicated for patients who have not responded to other forms of treatment, including surgery or radiation.
Acromegaly occurs in about 60 out of every million people and is usually caused by a benign tumor of the anterior pituitary gland, which leads to over-production of growth hormone.
The high levels of growth hormone spark hepatic production of insulin-like growth factor-1 (IGF-1), which in turn stimulates bone and tissue growth, leading to the characteristic signs and symptoms of the disorder:
Lanreotide, a somatostatin analogue, has been shown to lower levels of growth hormone as effectively as the other major medical therapy, octreotide.
In an open-label longitudinal study, the Italian Multicenter Autogel Study Group in Acromegaly reported in July that lanreotide and a long-release formulation of octreotide were equivalent in lowering serum levels of growth hormone and IGF-1.
At the same time, the study found, about half the lanreotide patients were able to take the drug every six to eight weeks without loss of efficacy, rather than the recommended monthly injection.
In the form approved by the FDA, the drug is a sustained-release, semi-solid formulation for injection without an inactive carrier. Instead, the active substance itself controls the sustained release, according to a statement from Tercica, Inc., of Brisbane, Calif., which will market the drug in the U.S.
The company said the medication -- delivered in pre-filled syringes -- will be available in about eight weeks.
Adverse events associated with the drug include moderate transitory injection site pain, abdominal pain, nausea and vomiting, diarrhea, gallstones, skin reactions such as itching, slow heart rate, and change in blood sugar levels.