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Gedeon Richter announces Levosert® (levonorgestrel intrauterine system) licence extension to five years of use for contraception and heavy menstrual bleeding

Gedeon Richter
Posted on: 04 Jan 19
  • levonorgestrel intrauterine system (IUS) licence extended to five years as contraception and to treat heavy menstrual bleeding, providing women with another five-year option for long-acting reversible contraception (LARC)[i]

 

MEDIA RELEASE FOR UK MEDICAL AND TRADE MEDIA ONLY

 

London, 02 January 2019 – Gedeon Richter Plc. (“Richter”) today announced that the licence for Levosert® (levonorgestrel intrauterine system (IUS)) has been extended to five years in its indications for contraception and the treatment of heavy menstrual bleeding.1 The licence extension was based on new five-year data that studied the efficacy and safety of levonorgestrel IUS in 1,751 women aged 16-45 years old, and found that it is effective and well-tolerated over five years of use.[ii]

 

The licence extension means that levonorgestrel IUS will now offer an additional five-year treatment option to women seeking long-acting reversible contraception (LARC). This comes after a recent BBC report highlighted some of the issues surrounding sexual and reproduction health services and access to contraception.[iii]

 

Dr Paula Briggs, Consultant in Sexual and Reproductive Health, said: “The extended licence for levonorgestrel IUS to five years is great news for women as it will mean replacing their IUS less frequently than before.”

 

An IUS is a type of LARC, which releases progestogen and can prevent pregnancy for three to five years. 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.[iv] 

 

LARC uptake in NHS sexual and reproductive health services nearly doubled between 2006/07 and 2016/17, with the number of women using LARC increasing to 39% versus 61% choosing user-dependent methods such as oral contraceptives.[v]

 

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]

 

“We are delighted. The licence extension to levonorgestrel IUS may allow women freedom to not worry about the risk of unplanned pregnancies for up to five years,” said Dr Kriszta Zolnay, 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 and for the treatment of heavy menstrual bleeding. Levonorgestrel IUS may be particularly useful in women with heavy menstrual bleeding requiring (reversible) contraception.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 (www.richter.hu), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe. Richter's consolidated sales were approximately EUR1.2 billion (US$1.6 billion) while its market capitalization amounted to EUR2.8 billion (US$3.8 billion) in 2013. The product portfolio of Richter covers almost all important therapeutic areas, including gynaecology, central nervous system, and cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the female healthcare field worldwide. Richter is also active in biosimilar product development.

 

Media Contacts

 

Shaad Cajee

Gedeon Richter

Marketing and Sales Executive

T: +44 (0)207 604 8809

E: info.uk@gedeonrichter.eu

Justine Brodie

Reynolds-MacKenzie

Senior Account Manager

T: +44 (0)207 861 2815

E: Justine@ReynoldsMackenzie.com

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 04/01/2019

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