Real-world safety results for Zoely® submitted to EMA

Theramex has announced that results from the post-authorisation safety study (PASS) for Zoely® (NOMAC-E2) have been submitted to the European Medicines Agency (EMA).¹

NOMAC-E2 (which combines nomegestrol acetate [2.5mg] and 17β-estradiol [1.5mg]), contains oestrogen with an identical structure to the one naturally produced by women.²

The prospective, non-interventional controlled cohort study, known as PRO E2, was designed to compare the risks of using NOMAC-E2 versus combined oral contraceptives containing levonorgestrel (COC-LNG).^1,3 The study, conducted by ZEG-Berlin, was required by the EMA and initiated in 2014 (following a precursor study, CELINA, initiated in 2012) and closed in Dec 2020.¹ The results reflect real world practice in more than 100,000 women from across Australia, Austria, Colombia, France, Germany, Hungary, Italy, Mexico, Poland, Russia, Spain, and Sweden.³

Professor Luis Iñaki Lete, Department of Gynecology, University Hospital Araba, Vitoria, Spain said: “As clinicians, real-world evidence and ongoing safety monitoring is increasingly important to the decisions we make on a day-to-day basis for our patients. Studies of this size help guide our clinical practice.”

NOMAC-E2 has previously been shown to induce significantly less change in the overall activity of the coagulation system in a study comparing it with levonorgestrel/ ethinylestradiol.⁴

References:

1. gov identifier: NCT01650168
2. Zoely® SMPC. Available at: https://www.medicines.org.uk/emc/product/3038/smpc. Last accessed April 2021.
3. Reed S et al, A ‘Real-World’ study population of NOMAC-E2 users and COC-LNG users: Baseline characteristics from the multinational PRO-E2 study. Pharmacoepidemiol Drug Saf. 2020;29(Suppl. 3):4
4. Gaussem, P et al. Thromb Haemost 2011;105:3
5. https://www.prnewswire.co.uk/news-releases/theramex-acquires-commercial-rights-for-oral-contraceptive-zoely-845938454.html