Regulatory Decision Summary for Yasmin Plus

Two pivotal studies (309763 and 310662) were submitted in support of the proposed indication "Improvement in folate status in women who choose to use oral contraception". Study 309763 demonstrated that plasma and Red Blood Cell (RBC) folate levels at week 24 of Yasmin Plus and Yasmin + 0.400 mg folic acid intake increased to a similar extent in both treatment groups, thereby demonstrating that Yasmin Plus is as effective as folic acid in improving levels of plasma and RBC folate. Study 310662 demonstrated that RBC folate and plasma folate levels at week 24 were significantly (p < 0.0001) higher for subjects who took Yaz Plus (an oral contraceptive similar to Yasmin Plus but with a lower amount of ethinyl estradiol) compared with subjects who took Yaz alone.

Addition of 0.451 mg levomefolate calcium to Yasmin for the purpose of folate supplementation, based on the data provided in this NDS, did not raise any new safety concerns. Study participants had the benefit of reliable contraception during the course of the study. The risk for the study participants consisted of the typical risks associated with the use of hormonal oral contraception.

Data from the pivotal bioequivalence study indicated that the performance of Yasmin Plus and Yasmin can be considered to be equivalent with respect to the delivery of ethinyl estradiol and drospirenone. The presence of levomefolate calcium did not appear to impact the delivery and absorption of drospirenone or ethinyl estradiol from Yasmin Plus relative to that observed from the currently marketed Yasmin tablets.

The data reviewed indicate that the risk/benefit profile of Yasmin Plus is consistent with that of Yasmin. Based on the results of the two long-term studies the benefit/risk profile for Yasmin Plus is favourable. The data submitted for this NDS support the proposed indications.