Levosert® (52mg levonorgestrel intrauterine system [IUS]) receives an 8-year licence extension in the UK for contraception

Levosert® (52mg levonorgestrel intrauterine system [IUS]) receives an 8-year licence extension in the UK                               for contraception[1]

·       Levosert is effective for 8 years in the contraception indication and has demonstrated efficacy for 3 years in the indication of heavy menstrual bleeding.¹ Therefore, Levosert should be removed or exchanged if heavy or bothersome menstrual bleeding returns or no later than 8 years if used clinically in line with contraceptive effectiveness. 1

London, 05 August 2024 – Gedeon Richter UK Ltd. (“Richter”) today announced that the Medicines Health Regulatory Authority (MHRA) has authorised an extension to the licence for Levosert from 6 to 8 years for contraception in the UK.1 The decision brings Levosert extended use in line with Mirena® (52mg levonorgestrel IUS) which received an 8-year UK licence earlier this year.[2]

The authorisation is based on results from the ongoing ACCESS IUS study in women aged 16-45 years old using Levosert.[3] The full 8-year cumulative pregnancy rate for Levosert is 1.09% (95% CI, 0.56-2.13).^3,[4] The pregnancy rate reported in ACCESS IUS is approximately 0.46% in years 6 to 8 for Levosert.⁴ Findings from ACCESS IUS demonstrate that 2 pregnancies (n=576) occurred in year 7 and 0 pregnancies (n=477) occurred in year 8,³ meaning Levosert was over 99% effective at preventing pregnancy during years 7 and 8.³

Dr Paula Briggs, Consultant in Sexual and Reproductive Health, says: “Having another 8-year option for long-acting reversible contraception (LARC) will be welcome news for the NHS at a time when sexual health services are under huge financial strain. Increasing the length of time the intrauterine system can be effective at preventing pregnancy can help lessen the burden of managing contraception for women, whilst the prolonged interval between procedures will further reduce pressures on the NHS.”

Levosert was well-tolerated over years 7 and 8, with the most commonly reported adverse events including vulvovaginal mycotic infection (n=42, 7.3%), vaginal bacterial infection (n=39, 6.8%) and acne (n=7, 1.2%).³  

An IUS is a type of long-acting reversible contraception (LARC), which releases progestogen and can prevent pregnancy for up to 8 years before needing to be replaced.^1,[5] It is a T-shaped plastic device that is inserted into the womb by a doctor or nurse and can be removed at any time, with pregnancy possible as soon as it is removed.⁵ 

The preference for LARC has increased since 2019, with 37% of women aged under 25 years and 53% of women aged over 25 years citing a form of LARC (excluding injectables) as their main method of contraception at sexual and reproductive health services.[6] These figures represent a rise in demand of 35% for under 25s and 23% for over 25s since 2019.⁶ By contrast, the use of user-dependent methods, such as oral contraceptives, has been on the decline over the last decade.[7]

Remigious Narauskas, Managing Director, Gedeon Richter UK, says: “Our dedication to women’s health and the sustainability of the NHS has been demonstrated with today’s announcement. We are delighted to offer the extended use of Levosert in its indication of contraception, allowing those who choose the intrauterine device as their contraceptive method to limit the number of insertion and removal procedures they might require. We will continue to support women and their healthcare professionals to make individual decisions that are right for them.”  

About Levosert

Levosert is an intrauterine delivery system that contains 52 mg levonorgestrel.1

Levosert has a demonstrated efficacy for 3 years for the indication heavy menstrual bleeding. Therefore, Levosert should be removed or exchanged if heavy or bothersome menstrual bleeding returns or no later than 8 years if used clinically in line with contraceptive effectiveness.1

Levonorgestrel IUSs prevent pregnancy by thinning the lining of the uterus, by making the normal mucus in the opening of the womb thicker so that the sperm cannot get through to fertilise the egg, and by preventing ovulation in some women.[8] Levonorgestrel IUS also reduces menstrual blood flow by thinning the lining of the uterus.⁸

About Gedeon Richter

Gedeon Richter has its headquarters in Budapest, Hungary, with UK offices based in London. The company's products are distributed in more than 100 countries and it employs around 13,000 people worldwide. Women’s Healthcare is a priority for Gedeon Richter UK; the company has extensive experience in this area and offers a comprehensive gynaecological portfolio.

For more information visit our UK website: Gedeonrichter.co.uk

References

[1] eMC. Gedeon Richter UK Ltd. Levosert 20 micrograms/24 hours Intrauterine Delivery System. Last updated: 1 Aug 2024. Available at: https://www.medicines.org.uk/emc/product/1789/smpc#gref Last accessed: August 2024 

[2] eMC. Bayer plc. Mirena 20 micrograms/24 hours intrauterine delivery system. Last updated on emc: 08 Jan 2024. Available at: https://www.medicines.org.uk/emc/product/1132 Last accessed: August 2024

[3] Creinin MD, Schreiber CA, Turok DK, et al. Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use. Am J Obstet Gynecol 2022;227:871.e1-7

[4] Letters to the Editors. Extending use of levonorgestrel 52 mg intrauterine device to 8 years. Am J Obstet Gynecol. Available at:  https://www.ajog.org/article/S0002-9378(23)00158-8/fulltext Last accessed: August 2024

[5] NHS, 2024. Intrauterine system (IUS). Available at: https://www.nhs.uk/conditions/contraception/ius-intrauterine-system/ Last accessed: August 2024

[6] FSRH, 2023. FSRH Statement on latest UKHSA and OHID Sexual and Reproductive Health profile statistics. Available at: https://www.fsrh.org/news/fsrh-statement-on-latest-ukhsa-and-ohid-sexual-and-reproductive/#:~:text=The%20statistics%20show%20that%20demand,for%20over%2025s%20since%202019 Last accessed: August 2024

[7] NHS Digital, 2022. Sexual and reproductive health services, England (Contraception) 2021/2022. Available at: https://digital.nhs.uk/data-and-information/publications/statistical/sexual-and-reproductive-health-services/2021-22/methods-of-contraception Last accessed: August 2024

[8] MHRA, 2018. Public Assessment Report (UKPAR). Available at: http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con870422.pdf Last accessed: August 2024