Gedeon Richter Reintroduces Dydrogesterone-Only HRT Option to UK Market After 17-Year Absence
核心洞察
Gedeon Richter UK has launched Nalvee (搜索) (10mg dydrogesterone), marking the return of a dydrogesterone-only hormone replacement therapy formulation after more than 17 years of absence from the UK market.
The oral tablet offers clinicians a new progestogen option for non-hysterectomised women receiving oestrogen (搜索) therapy, with clinical studies showing 97% success in endometrial protection.
Dydrogesterone closely mimics natural progesterone with high bioavailability and specificity for progesterone receptors (搜索), allowing efficacy at doses 10 to 20 times lower than micronised progesterone.
Gedeon Richter UK has launched Nalvee (搜索) (10mg dydrogesterone) in the UK, marking the return of a dydrogesterone-only formulation for hormone replacement therapy after more than 17 years. The oral tablet offers clinicians a new progestogen option for non-hysterectomised women receiving oestrogen (搜索) therapy, addressing what the company describes as a significant gap in HRT treatment options.
Return of a Proven Therapy
Nalvee (搜索) is a branded generic of a product first introduced in 1961 but withdrawn from the UK market in 2008 due to declining HRT use following misreported data from the Women's Health Initiative (WHI) linking hormone replacement therapy to increased risks of breast cancer (搜索) and blood clots. The original product, Duphaston, remains available in other European markets where it is marketed by Theramex, and has maintained a favourable safety profile from over 60 years of clinical use.
The drug was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in June 2024, and can be used in combination with any oral or transdermal oestrogen (搜索) HRT.
Clinical Advantages and Efficacy
Dydrogesterone closely mimics natural progesterone and is highly bioavailable, with high specificity for progesterone receptors (搜索) that allows efficacy at low doses—10 to 20 times lower than micronised progesterone. Clinical studies have demonstrated that dydrogesterone given as a 10mg tablet was able to protect the womb lining from unwanted effects of oestrogen (搜索), such as endometrial hyperplasia (搜索), in 97% of cases.
A meta-analysis of four studies showed that dydrogesterone combined with oestradiol produced well-tolerated bleeding profiles. Most women reported slight cyclical bleeds with predictable duration, which research suggests enhances treatment satisfaction. Studies indicate that women experiencing cyclical bleeds reported them as slight with highly predictable duration when using dydrogesterone sequentially in combination with oestradiol.
Addressing Treatment Discontinuation
The launch addresses a key clinical challenge in HRT management. Dr Paula Briggs, Consultant in Sexual and Reproductive Health, explained: "One of the major reasons given by women for discontinuing HRT is the return of bleeding often requiring further investigation. This dydrogesterone-only treatment, with its favourable endometrial safety profile and predictable, lighter bleeding patterns, gives clinicians another option to personalise HRT to enhance patient satisfaction."
Market Impact and Company Commitment
Remigijus Narauskas, Managing Director of Gedeon Richter UK, stated: "We are delighted to launch Nalvee (搜索) in the UK market, providing an additional progestogen option for menopause (搜索) treatment. With this growth of our HRT portfolio, we are underscoring our dedication to women's health."
The reintroduction comes as HRT use has begun to recover from the significant decline that followed the initial WHI publication, though usage has not yet reached the levels seen in the early 2000s before those results were first published. The availability of Nalvee (搜索) means women in the UK have regained access to a treatment that some clinicians assert is better tolerated than other synthetic, micronised progestogens.