Regulatory Decision Summary for SOMAVERT
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of the current Supplement to a New Drug Submission (SNDS) is to seek authorization of the use of Somavert (pegvisomant for injection) as first-line pharmacotherapy of patients with acromegaly and who have had an inadequate response to surgery, and/or radiation therapy. The goal of treatment is to normalize serum insulin-like growth factor-I (IGF-I) levels and to improve clinical signs and symptoms.
Why was the decision issued?
This SNDS was primarily supported by safety data gathered since the original New Drug Submission (NDS). No specific efficacy study was conducted to support the change to the indication. The additional safety information submitted is reassuring and found similar to those previously reported. No new safety concern has been identified.
Hence, the restriction, for lack of long term safety, of the indication of Somavert as 2nd line pharmacotherapy, at the time of the original NDS is no longer deemed necessary. Therefore, based on the totality of evidence provided and taking into consideration the change in the standard of care in Canada for acromegaly, the Benefit and Risk of Somavert as first-line pharmacotherapy, on par with other authorized drugs, at an adequate titration to an optimum dose for the indication sought, is considered favorable.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations