About SOMAVERT® (pegvisomant for injection) | Safety Info

SOMAVERT significantly lowered IGF-I levels

SOMAVERT was studied in a clinical trial for 12 weeks in 112 patients. Patients were given either a daily dose of SOMAVERT at 10 mg, 15 mg, or 20 mg, or they were given a placebo.

For all 3 doses in the 12-week clinical trial, SOMAVERT:

Significantly lowered
IGF-I levels at 12 weeks

Rapidly reduced IGF-I
levels within 2 weeks*

Worked for 2 out of 3 patients to achieve normal IGF-I levels*

In a long-term extension of the study that involved 109 patients, 93% of those patients had normal IGF-I levels during at least 1 doctor visit while taking SOMAVERT for an average of 43 weeks.

* These data are from a clinical trial that involved 112 patients with acromegaly. Thirty-two patients received a placebo. Eighty were treated with SOMAVERT at 1 of 3 dosage strengths. The primary efficacy endpoint was IGF-I percent change in IGF-I concentrations from baseline to week 12. The mean percent change from baseline in IGF-I was -4 for placebo, -27 at 10 mg/day, -48 at 15 mg/day, and -63 at 20 mg/day for SOMAVERT. Seventy-five percent of the total mean reduction in IGF-I levels occurred within 2 weeks and the reduction was sustained over the 12-week course of therapy with all doses of SOMAVERT (this was not part of the primary endpoint). Results of the secondary endpoint for percent of patients achieving normal IGF-I levels for their age were 10% of patients taking a placebo, 39% of those on 10 mg of SOMAVERT per day, 75% of those on 15 mg of SOMAVERT per day, and 82% of those on 20 mg of SOMAVERT per day. The total percentage of patients taking SOMAVERT who achieved normal IGF-I levels at week 12 was 65% (51 out of 78 patients).

These data come from the extension to the original clinical study of 109 patients (including 6 new patients).

IGF-I, insulin-like growth factor I.