30 September 2021
29 September 2021
London, 21st September 2021: Theramex has announced approval of Bijuva® / Bijuve® (1mg estradiol / 100mg progesterone) across Europe and the UK. Bijuva®, (known as Bijuve® in the UK), is the first, and only, body-identical hormone therapy treatment (HRT) for estrogen deficiency symptoms in post-menopausal women with intact uterus and at least 12 months since last menses, which combines estradiol and progesterone in a single daily oral capsule.1,2 Unlike synthetic hormone products, the estradiol and progesterone found in Bijuva® / Bijuve® are chemically and biologically identical to the hormones naturally circulating in the woman’s body.3
Real-world evidence, recognised by NICE and the British Menopause Society, suggests that use of body‑identical hormones is associated with lower risks compared to synthetic versions. 4,5 In particular, the evidence base demonstrates that body-identical hormones have not been shown to increase the risk of venous thromboembolism and are safer forms of HRT with respect to the risk for breast cancer, heart disease, heart attack, and stroke.6-8
Dr Paula Briggs, incoming Chair of the British Menopause Society, said, “We know women can be concerned about taking hormones and the impact they may have on their health beyond treating menopause symptoms. The availability of a body-identical progesterone which is well tolerated and has a lower risk profile than oral synthetic progestogens, combined with estradiol in a single capsule, is great news for women. As a healthcare community we should encourage our patients to reconsider the benefits of newer therapeutic options, allowing them to make informed choices.”
Theramex CEO, Robert Stewart, commented, “For many years menopausal women and their healthcare providers have been seeking an EMA approved bio-identical combination therapy. The approval of Bijuva® / Bijuve® represents an important new opportunity for menopausal women suffering from moderate to severe vasomotor symptoms.”
*with intact uterus and at least 12 months since last menses
1 Theramex 2021, Summary of Product Characteristics
2 FDA Summary Review. 2018. Available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210132Orig1s000SumR.pdf. Accessed September 2021.
3 Kuhl H. Pharmacology of estrogens and progestogens: influence of different routes of administration. Climateric. 2005;8(Suppl 1):3-63.
4 National Institute for Health and Care Excellence. Menopause: diagnosis and management (NG23). 2015. Available at https://www.nice.org.uk/guidance/ng23/. Accessed September 2021.
5 British Menopause Society. The British Menopause Society & Women’s Health Concern 2016 recommendations on hormone replacement therapy in menopausal women. 2016. Available at https://thebms.org.uk/publications/consensus- statements/hormone-replacement-therapy/. Accessed September 2021.
6 Holtorf K. The bioidentical hormone debate: are bioidentical hormones (estradiol, estriol, and progesterone) safer or more efficacious than commonly used synthetic versions in hormone replacement therapy. Postgrad Med. 2009;121(1):73–85.
7 Mirkin S. Evidence on the use of progesterone in menopausal hormone therapy. Climateric. 2018;21(4):346-354.
8 Fournier A, Berrine F, Clavel-Chapelon F. Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study. Breast Cancer Res Treat. 2008;107:103-111.