Gedeon Richter announces Levosert® becomes the UK’s first and only IUS to receive six-year licence extension for contraception

Gedeon Richter announces Levosert® becomes the UK’s first and only IUS to receive six-year licence extension for contraception

• The licence extension for Levosert® (levonorgestrel intrauterine system (IUS)) in its indication for contraception means women will now be able to choose a six-year treatment option for long-acting reversible contraception (LARC).[i]
• Levonorgestrel IUS is also licensed for women requiring treatment for heavy menstrual bleeding (HMB) for up to 5 years.1

MEDIA RELEASE FOR UK MEDICAL AND TRADE MEDIA ONLY

London, 19 January 2021 – Gedeon Richter Plc. (“Richter”) today announced that the licence for Levosert® (levonorgestrel intrauterine system (IUS)) has been extended to six years in its indication for contraception, making it the first and only IUS available in the UK to receive this.1 The licence extension was based on a six-year study which investigated the efficacy and safety of levonorgestrel IUS in 1,751 women aged 16-45 years old, and found that it continued to be effective and well-tolerated over six years of use.[ii]

Dr Paula Briggs, Consultant in Sexual and Reproductive Health, said: “This licence update means that the IUS can now be used for up to six years in contraception and allows women to continue with their contraception for a longer period. This news also lessens the burden of having to manage their contraception by allowing even more time between needing their IUS replaced, with the potential to also reduce workload for the NHS.”

An IUS is a type of long-acting reversible contraception (LARC), which releases progestogen and can prevent pregnancy for three to six years.1^,3 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.[iii] 

LARC uptake in NHS sexual and reproductive health services has steadily increased in recent years, with the number of women using LARC increasing to 41% versus 39% in in 2017.[iv]^,[v] The use of user-dependent methods, such as oral contraceptives, is on the decline with 56% of women using these methods versus 61% in 2017.4^,5

The National Institute for Health and Care Excellence (NICE) currently recommends a levonorgestrel-releasing IUS as first-line treatment for women suffering from heavy menstrual bleeding with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or suspected or diagnosed adenomyosis.[vi]

“Our driving commitment to women’s health has taken a significant step forward with today’s announcement. We are delighted to be able to provide women with the only IUS in the UK that allows for up to six years contraception,” said Tamás Neubauer, Managing Director of Gedeon Richter UK.

About levonorgestrel IUS

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

Levonorgestrel IUS is indicated for contraception for up to six years and for the treatment of heavy menstrual bleeding up to five years.1 Therefore, it should be removed after five or six years of use, according to the indication.1

Levonorgestrel IUS prevents 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. Levonorgestrel IUS also reduces menstrual blood flow by thinning the lining of the uterus.[vii]

About Gedeon Richter

Gedeon Richter has its headquarters in Budapest, Hungary, with UK offices based in London. It is a

multinational pharmaceutical company that specialises in women’s health. The company's products

are distributed in more than 100 countries and it employs around 11,000 people worldwide.

Women’s Healthcare is a priority for Gedeon Richter, the company has several decades of extensive

experience in this area and offers a comprehensive gynaecological portfolio.

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