Gedeon Richter brings HRT option back to the UK market

Gedeon Richter has launched a dydrogesterone-only hormone replacement therapy (HRT) formulation in the UK, Nalvee, as an option for non-hysterectomised women receiving oestrogen therapy.

Nalvee marks a return to the market for a dydrogesterone-only product after an absence of 17 years, and can be used in combination with any oral/transdermal oestrogen HRT. It is a branded generic version of a product called Duphaston – originally launched in 1961 – that was withdrawn from sale in the UK in 2008.

That decision was taken for commercial reasons, with sales declining in light of the reduced use of HRT that followed the publication of misreported data from the Women's Health Initiative (WHI) linking it to increased risks of breast cancer and blood clots. Since then, use of HRT has started to recover, but has not reached the levels seen in the early 2000s before the WHI results were first published.

Duphaston remains on the market in other European markets, where it is marketed by Theramex, and the launch of Nalvee means women in the UK have now regained access to a drug that some clinicians assert is better tolerated than other synthetic, micronised progestogens.

Progestogens are incorporated into HRT to protect the endometrium from the effects of oestrogen given alone and support a favourable bleeding pattern. Dydrogesterone closely mimics natural progesterone and is highly bioavailable, with a high specificity for progesterone receptors, allowing efficacy at low doses – around 10 to 20 times lower than micronised progesterone.

According to Gedeon Richter, clinical studies have shown that dydrogesterone given as a 10mg tablet – the same presentation as in Nalvee – was able to protect the womb lining from unwanted effects of oestrogen, such as endometrial hyperplasia, in 97% of cases.

It also pointed to studies showing that dydrogesterone, given sequentially in combination with oestradiol, achieved a well-tolerated bleeding profile in the majority of women, with those experiencing cyclical bleeds "reporting them as slight and the duration as highly predictable."

"One of the major reasons given by women for discontinuing HRT is the return of bleeding, often requiring further investigation," said Dr Paula Briggs, an NHS consultant in sexual and reproductive health.

"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," she added.

Nalvee was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in June 2024.

Gedeon Richter said in a statement that its return to the UK market "addresses a significant gap in HRT and emphasises Gedeon Richter's commitment to women by providing more choice for the treatment of the menopause."

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