Gedeon Richter receives licence for the first and only reloadable, single-handed intrauterine delivery system (IUS) for contraception in the UK

Gedeon Richter receives licence for the first and only reloadable, single-handed intrauterine delivery system (IUS) for contraception in the UK

London, United Kingdom, Wednesday 03 November 2021 – Gedeon Richter UK Ltd. (“Gedeon Richter”) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a UK licence for Benilexa® One Handed (levonorgestrel IUS), as a type of contraception and for the treatment of heavy menstrual bleeding in women of fertile age.¹ This means that healthcare professionals and eligible women now have access to a reloadable, single-handed IUS for the first time on the NHS in the UK.¹ The list price of levonorgestrel IUS is £71.

Levonorgestrel IUS is effective for six years as a contraceptive, and has been shown to be effective for three years in treating heavy menstrual bleeding.¹ Levonorgestrel IUS should be removed or exchanged after six years of use, or earlier if heavy or bothersome menstrual bleeding returns.¹ 

“Unlike other single-handed IUSs, this levonorgestrel IUS inserter is reloadable, providing reassurance that if loaded incorrectly in the insertion device, we can reposition and reload it,” said Dr Paula Briggs, Consultant in Sexual and Reproductive Health at Liverpool Women’s NHS Foundation Trust.

The UK licence is based on outcomes from two Phase 3 trials, one investigating the contraceptive protection of levonorgestrel IUS (“Access IUS study”) and the other evaluating women with heavy menstrual bleeding[*] (“menstrual blood loss study”)

Pivotal data from the Access IUS study showed that the cumulative pregnancy rate calculated by the Pearl Index[†] in women aged 16 to 35 years using levonorgestrel IUS (primary endpoint), was 0.15 (17,125 cycles, 95% CI: 0.02, 0.55) at the end of year one and 0.18 (66,457 cycles, 95% CI: 0.08, 0.33) at the end of year six.¹,² There were two on-treatment pregnancies in the first year, four further pregnancies in the second year, one additional pregnancy in the third, fourth, and fifth years, and no pregnancy in the sixth year.² This means that out of 66,457 cycles, nine women fell pregnant on-treatment.²

In the menstrual blood loss study, pivotal data showed that levonorgestrel IUS achieved a significant reduction in menstrual blood loss within three to six months of treatment.¹ The volume of

menstrual bleeding decreased by 88% in women with heavy menstrual bleeding by the end of three months of use and 82% reduction was sustained for the duration of the study (12 months).¹ The effect was maintained during the extension phase of the study (up to 36 months).¹

The most common adverse events (occurring in ≥10% of users) for levonorgestrel IUS include uterine/vaginal bleeding, oligomenorrhoea (infrequent menstrual periods), amenorrhoea (absence of menstrual periods), and benign ovarian cysts.¹

The levonorgestrel IUS is designed for simple insertion, and rated as easy by 88% of treating clinicians.³ The inserter is partially preloaded with the levonorgestrel IUS.¹ The levonorgestrel IUS consists of a T-shaped polyethylene frame (T-frame) with a drug reservoir around the vertical stem.¹    

“The granting of a licence for levonorgestrel IUS is a positive outcome for healthcare professionals and women who want long-term birth control or to treat heavy periods. We are delighted that the value of this IUS has been recognised,” said Tamas Neubauer, Managing Director UK and Ireland, Gedeon Richter. “We want to support women, whatever life might bring. The addition of levonorgestrel IUS to our existing portfolio of emergency contraceptives, intrauterine systems and the transdermal patch, underscores our ambition to address all the healthcare needs of women throughout the UK.”  

References

[*]≥ 80 mL per menstrual cycle.

[†]An estimation of the number of unintended pregnancies per 100 women-years of exposure. The Pearl Index is calculated as the number of on-treatment pregnancies in the study, divided by the total number of complete 28-day cycles of use, that result multiplied by 1,300 (13 cycles x 100 years). 

[1] Gedeon Richter. Benilexa One Handed 20 micrograms/24 hours Intrauterine Delivery System. Summary of Product Characteristics.

[2] Westhoff CL., et al. Six-year contraceptive efficacy and continued safety of a levonorgestrel 52 mg intrauterine system. Contraception. 2020; 101(3): 159-161.

[3] MHRA. Levosert 20 micrograms/24 hours Intrauterine Delivery System. UK Public Assessment Report.