Regulatory Decision Summary for Rekovelle
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 New Drug Submission sought approval of Rekovelle (follitropin delta solution for injection) for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
A Notice of Deficiency (NOD) was issued on November 21, 2016 based on the fact that the selected co-primary endpoints were judged not to be appropriate to support the proposed indication. Biologics and Genetic Therapies Directorates (BGTD) comments were further explained to the sponsor in a NOD response meeting on February 17, 2017. The response to the NOD has been reviewed as part of this submission and judged to be acceptable; the main deficiency issues were addressed and the minor deficiency issues were mitigated via revisions to the proposed Product Monograph.
Why was the decision issued?
This New Drug Submission seeks approval for Rekovelle (follitropin delta solution for injection) for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Rekovelle is a recombinant human follicle stimulating hormone (rhFSH) derived from a human cell line. It differs from other marketed rFSH treatments as it is to be administered with an individualised dosing regimen, based on the patients serum anti-Müllerian hormone (AMH) level and body weight. With these parameters, a specific daily dose of Rekovelle is determined for each patient from the start of the ART cycle.
Evidence of safety and efficacy of Rekovelle was provided in 2 clinical trials. The ESTHER-1 trial demonstrated non-inferiority of Rekovelle compared to GONAL-F with respect to ongoing pregnancy rate and ongoing implantation rate in women undergoing controlled ovarian stimulation. The ESTHER-2 trial demonstrated that the immunogenicity of Rekovelle was similar to GONAL-F in women undergoing repeated controlled ovarian stimulation cycles. The efficacy of Rekovelle was acceptable for the indication sought.
The major risk factor for patients undergoing fertility treatment with Rekovelle is development of ovarian hyper stimulation syndrome (OHSS). Based on the submitted data, the safety profile in patients treated with Rekovelle is considered acceptable. The Product Monograph was revised in order to reflect the reported safety findings.
Overall, the benefit / risk ratio of Rekovelle for controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle is considered acceptable.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.