Source: Head & Neck  |  Posted 6 years ago

First in a new class of medications provides effective treatment option for life-shortening endocrine disease

MONTREAL, CANADA -- January 24, 2006 -- Health Canada has approved Somavert (pegvisomant for injection) for the treatment of patients with acromegaly who have had an inadequate response to surgery, radiation therapy and other medical therapies, or for whom these therapies are not appropriate. Somavert is the first in a new class of medications called growth hormone receptor antagonists designed specifically to block the effects of excess growth hormone.

Acromegaly is a rare, life-shortening disease triggered by over-secretion of growth hormone that leads to overproduction of a second hormone, insulin-like growth factor-1 (IGF-1). Usually caused by a pituitary tumour, acromegaly results in progressive distortion of facial features and enlargement of the hands, feet, jaw and internal organs.

More than 90% of patients with acromegaly were controlled on Somavert in clinical trials. The goal of acromegaly treatment is to normalize serum IGF-1 levels.

"Since current therapies do not always control the disease, Somavert represents an important new option for the treatment of acromegaly," said Dr. Shereen Ezzat, Professor of Medicine and Oncology, University of Toronto and Head, Endocrine Oncology Site Group, Princess Margaret Hospital.

Current treatments for acromegaly include surgery to remove the pituitary tumour, radiation therapy and medication. A high percentage of post-surgical patients still require medical therapy and, despite current drug treatment options, 35% to 50% continue to live with uncontrolled acromegaly.

On average, uncontrolled acromegaly will shorten a patient's lifespan by 10 years due to long-term complications such as cardiovascular and respiratory disease, diabetes mellitus and some forms of cancer. People with acromegaly often suffer from headaches, excessive sweating, soft-tissue swelling and joint disorders, severely impairing their quality of life.

"Pfizer is committed to bringing new treatments to Canadians that address an unmet medical need," said Bernard Prigent, Vice-President & Medical Director, Pfizer Canada. "We're very pleased to make Somavert available to the many patients with acromegaly for whom current therapies do not control the disease."

Based on published prevalence data, it is estimated that 40 to 60 people per million live with acromegaly in Canada. This translates to approximately 1,500 to 2,000 Canadians with the disease. Diagnosis is often delayed for up to 15 years after symptoms begin.

All patients with growth hormone-secreting pituitary tumours should be carefully monitored in order to avoid any progression in tumour size. A growth hormone-deficient state may result from Somavert administration, despite the presence of elevated serum growth hormone levels. Serum IGF-1 concentrations should be monitored and maintained within the age-adjusted normal range by adjustment of Somavert dosing. Insulin sensitivity may increase following initiation of treatment with Somavert; thus in patients with diabetes mellitus, the doses of insulin or oral hypoglycemic medicinal products may need to be decreased.

The most commonly reported adverse events related to Somavert occurring in more than 5% of patients during clinical trials were injection site reactions (11%), sweating (7%), headache (6%) and asthenia (6%). Most injection site reactions, characterized as localized erythemas and soreness, spontaneously resolved with local symptomatic treatment while Somavert therapy continued. Somavert is contraindicated in patients with hypersensitivity to pegvisomant or any of its excipients.

SOURCE: Pfizer Canada