Regulatory Decision Summary for Lupron Depot
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?
This Supplement to a New Drug Submission (SNDS) was filed to obtain market authorization for the Lupron Depot 3.75 mg (1-Month slow release) to be used concomitantly with iron therapy is indicated for the preoperative hematologic improvement in women of reproductive age with anemia caused by uterine leiomyomata (uterine fibroids).
Why was the decision issued?
A pivotal, comparative, phase III, stratified, randomized, double-blinded, parallel-group, multicenter study (Study M90-411), consisting of a 12-week treatment period and a 6-month follow-up, demonstrated no differences in efficacy parameter results between both dosage forms of leuprolide acetate (7.5 mg and 3.75 mg), with a slightly better safety profile at the lower dose in the same study population. Therefore, only the 3.75 mg dosage form of leuprolide acetate was considered for this indication.
Gonadotropin-releasing hormone (GnRH) agonist therapy is associated with a slight and apparently transient decrease in bone mineral density (BMD). A 6-month course of GnRH agonist therapy resulted in a 5% to 7% loss in spine BMD as measured by quantitative computed tomography, with a corresponding loss of 2% to 6% by Dual-photon absorptiometry. For the recommended indication, the duration of use is up to three months only.
The benefits of up to 3-month treatment course of 3.75 mg of leuprolide acetate for surgical candidates with anemia caused by uterine leiomyomata outweigh the risk of experiencing Adverse Events, which are mainly related to the physiologic hypoestrogenism induced by leuprolide acetate, and the risk of a slight and apparently transient decrease in BMD.
Based on the data submitted, Health Canada considers that the anticipated benefits outweigh the potential risks under the conditions of use described in the Product Monograph.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations