Pharmacia Corporation announced that the European Commission has approved Somavert (pegvisomant powder and solvent for solution for injection) for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerated.
Acromegaly is a serious, life-shortening disease triggered by over-secretion of growth hormone, most often caused by a pituitary tumour. This excess of growth hormone leads to overproduction of a second hormone, IGF-I, (insulin-like growth factor-l), which causes the disabling symptoms and the long-term health problems associated with the disorder.
Somavert is the first in a new class of medicines called growth hormone receptor antagonists. Somavert was studied in a randomised clinical trial and in two long-term open label dose adjusted studies in patients with acromegaly. In the long-term studies, Somavert normalised concentrations of IGF-I in more than 90 percent of patients.IGF-I is a measure of the activity of acromegaly, and achieving a normal IGF-I level is a fundamental goal of acromegaly treatment.
Somavert is the first and only medicine designed to specifically block the effects of growth hormone and is currently under review by the US Food and Drug Administration (FDA).
"Somavert is a significant advance in the medical management of acromegaly," said Peter J. Trainer, Consultant Endocrinologist, Christie Hospital, Manchester, U.K. and lead author of the pivotal Somavert study published by the New England Journal of Medicine. "The approval of this medicine ensures that patients in Europe suffering from acromegaly will soon have access to an additional effective medical treatment for this disease."
"Now that we have the Commission's approval, we look forward to making this important new treatment available to patients in Europe suffering from acromegaly in the coming months," said Peter Rost, Vice President, Endocrine Care, Pharmacia Corporation."The development of Somavert is another example of our commitment to global leadership in endocrine care."
Patients with acromegaly often suffer from headache, excessive sweating, soft-tissue swelling, joint disorders and, perhaps most striking, a progressive coarsening of facial features and enlargement of the hands, feet and jaw.Untreated, patients with acromegaly face a mortality rate two to four times higher than the average person, due to such serious long-term complications as heart and respiratory diseases, diabetes mellitus and some forms of cancer. The number of people with acromegaly is estimated at 40,000 in Europe, the USA and Japan, but experts believe the prevalence may be much higher as diagnosis is often delayed for up to 15 years after symptoms begin. Traditional treatments for acromegaly include surgery to remove the pituitary tumour, radiation therapy and pharmaceutical treatments.