Mirena ® approved in Europe for extended duration of use in contraception
Mirena ®( 52 mg LNG IUS), Bayer’s long- acting reversible intrauterine system, entered nonsupervisory blessing in the European Workshare Procedure for over to eight times in contraception, now offering the longest contraceptive duration of use for any hormonal intrauterine system – public blessings anticipated in Q4 The IUS is one of the most effective birth control styles Mirena was also approved for the treatment of idiopathic menorrhagia( heavy menstrual bleeding) for over to eight times if symptoms haven’t returned before
Bayer, a leader in women’s healthcare, blazoned moment that it has appreciatively concluded the European Workshare Procedure extending the duration of use for over to eight times in contraception of its levonorgestrel( LNG) releasing intrauterine system( IUS) Mirena ® for countries inEurope.This nonsupervisory blessing in Europe is grounded on the results of the Mirena Extension Trial assessing the efficacity and safety of Mirena which demonstrated that contraceptive efficacity remains high with lesser than 99 during times six to eight of use. Following the completion of the European Workshare procedure the first public blessings in the EU are anticipated in Q4 2022.
“ With the positive concurrence of the blessing process in Europe we’re pleased to be suitable to offer soon the extended marker also to women in Europe and with this perfecting the range of contraceptive styles as individual contraceptive requirements are changing throughout the reproductive life ”, saidDr. Michael Devoy, Chief Medical Officer at Bayer AG.
The European blessing also includes symptom driven extended use for the suggestion idiopathic menorrhagia( heavy menstrual bleeding) for over to eight times or until symptoms return. The IUS should be removed or replaced after eight times at the rearmost.
In August 2022, Bayer enteredU.S. blessing for the extended duration of use for over to eight times in the contraception suggestion for its levonorgestrel( LNG) releasing intrauterine system( IUS) Mirena.
A LNG- IUS is one of the most effective birth control styles as it doesn’t bear stoner compliance similar as diurnal dosing or yearlyre-fills. It can be removed by the croaker
at any time and offers a rapid-fire return to a woman’s natural position of fertility after junking. A LNG- IUS should only be fitted after a comprehensive discussion and evaluation of all contraceptive options and the individual woman’s requirements.
About the Contraceptive Efficacy & Mirena Extension Trial
The contraceptive efficacity of Mirena for over to five times has been studied in five large clinical trials involving,330 women. The Pearl Index was about0.2 in the first time and cumulatively, contraception failed by about0.7 over five times. The contraceptive effectiveness of Mirena after further than five times( including times six to eight) was studied in the Mirena Extension Trial. Grounded on 2 gravidity( 1 in Year 6 and 1 in Year 7) and,216 exposure cycles, the accretive gestation rate at the end of the 3- time period of extended use( Times 6, 7 and 8) was0.68 with a 95 upper confidence limit of2.71. The study verified a positive benefit threat profile with no new or unanticipated safety findings. The eight- time data from the extension trial were published in abstract form at the American College of Obstetricians and Gynecologists( ACOG) in 2022. The full paper is published in the American Journal of Obestetrics and Gynecology at https//doi.org/10.1016/j.ajog.2022.09.007. Information about this trial can be set up at https//clinicaltrials.gov/ ct2/ show/ study/ NCT02985541.
About Mirena ®
Mirena is a T- shaped device containing 52 mg of synthetic levonorgestrel. Once placed in the uterus, it continuously releases small quantities of levonorgestrel directly into the uterus. Mirena is a long- acting reversible contraceptive( LARC) and can be removed at any time by a healthcare provider if a woman’s plans change. Mirena is available in numerous countries over all mainlands.
About Women’s Healthcare at Bayer
Bayer is a honored leader in the area of women’s healthcare, with a long-standing commitment to delivering wisdom for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long- acting birth control styles as well as curatives for menopause operation and gynecological conditions. Bayer is also fastening on innovative options to address the unmet medical requirements of women worldwide. moment, Bayer’s exploration and development sweats concentrate on chancing new treatment options for menopause as well as gynecological conditions and includes several composites in colorful stages ofpre-clinical and clinical development. Together, these systems reflect the company’s approach to exploration, which prioritizes targets and pathways with the eventuality to alter the way that gynecological conditions are treated. also, Bayer intends to give 100 million women in low- and-middle income countries by 2030 with access to family planning by fundingmulti-stakeholder aid programs and by icing the force of affordable ultramodern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.
Bayer is a global enterprise with core capabilities in the life wisdom fields of health care and nutrition. Its products and services are designed to help people and the earth thrive by supporting sweats to master the major challenges presented by a growing and growing global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and produce value through invention and growth. The Bayer brand stands for trust, trustability and quality throughout the world. In financial 2021, the Group employed around,000 people and had deals of44.1 billion euros. R&D charges before special particulars amounted to5.3 billion euros.