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Yahoo
13-03-2025
- Health
- Yahoo
Gedeon Richter's once-daily endometriosis pill approved for NHS use
The UK's National Institute for Health and Care (NICE) has approved Gedeon Richter's Ryeqo (relugolix–estradiol–norethisterone), a once-daily oral treatment for endometriosis, for use on the National Health Service (NHS). The drug works by blocking gonadotrophin releasing hormone (GnRH) that contributes to endometriosis while simultaneously providing necessary hormone replacement. Unlike traditional GnRH agonists – such as Takeda's Prostap (leuprorelin) and AstraZeneca's Zoladex (goserelin) – which are limited to six months of use, Ryeqo can be taken until menopause. NICE estimates that around 1,000 women per year could benefit from the treatment, which has a list price of £72 per 28-day pack. Helen Knight, director of medicines evaluation at NICE, highlighted the benefits of a pill-based treatment: 'Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home. The treatment can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side effects.' Endometriosis, a condition where tissue similar to the womb lining grows outside the uterus, causes severe pain, heavy periods, fatigue and fertility issues. Current treatment options include pain relief, hormonal therapy, and surgery. Ryeqo is now an option for those who have previously undergone medical or surgical treatments but found alternatives like tranexamic acid, hormonal contraceptives, and intrauterine delivery systems ineffective or unsuitable. NICE's final draft guidance emphasised the need for non-invasive, long-term treatment options for endometriosis symptoms, as there is no cure. Charities, including Endometriosis UK, welcomed the news, but noted that Ryeqo induces a state of 'medical menopause' alongside hormone replacement therapy (HRT), meaning it may only be suitable for 'a small proportion of the 1.5 million with the disease'. NICE reversed its previous negative stance on the drug after Gedeon Richter provided additional evidence on the drug's effectiveness and cost-effectiveness. Ryeqo improved endometriosis-associated pain and was well tolerated compared to placebo in the Phase III SPIRIT 1 (NCT03204318) and SPIRIT 2 (NCT03204331) clinical studies, which enrolled over 1,200 women. Beyond the approval of new treatments, Endometriosis UK has called for greater investment in research to find the root cause of the disease, improve management strategies, and to develop a cure. At the Royal Society of Medicine's Innovation in Women's Health and Femtech meeting on 3 March 2025, McKinsey partner Anouk Petersen pointed out that despite affecting a similar proportion of the population as diabetes (about 10%), endometriosis receives eight to ten times less funding. A report from McKinsey & Company and the World Economic Forum underscored the economic impact of conditions like endometriosis, finding that while women live longer than men, they spend 25% more of their lives in debilitating health conditions. This has direct productivity consequences, with 60% of the gender health gap occurring during prime working years, contributing to 80% of the economic burden on gross domestic product (GDP). According to GlobalData's Pharma Intelligence Center, Ryeqo is forecast to generate up to $775m in sales in 2030. GlobalData is the parent company of Pharmaceutical Technology. "Gedeon Richter's once-daily endometriosis pill approved for NHS use" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Telegraph
13-03-2025
- Health
- Telegraph
New endometriosis pill not available to most women with condition
A new pill to treat endometriosis that is to be made available on the NHS will not be prescribed to most women with the condition, it has emerged. The combination drug has been approved by the National Institute for Health and Care Excellence (Nice), the watchdog, to treat women in England who suffer from the debilitating condition. However, it will only be made available on the NHS for patients whose medical or surgical treatment for endometriosis has failed – around 1,000 women out of the 1.5 million who have the condition in the UK. The drug – known as relugolix combination therapy or Ryeqo – is the first long-term daily pill licensed to treat the condition. It works by blocking specific hormones that contribute to endometriosis, while also providing necessary hormone replacement. Unlike current injectable treatments, which can initially worsen symptoms, the pill can be taken at home, works more quickly, combines hormones, and cuts the need for visits to clinics. Endometriosis occurs when cells similar to those in the lining of the womb grow in other parts of the body, such as the pelvis, bladder and bowel. It can cause severe pain, heavy periods, exhaustion and fertility problems. The charity Endometriosis UK said it noted the drug may be suitable for only a small proportion of the 1.5 million women with the condition. 'For those with a history of previous medical or surgical treatment for their endometriosis, Relugolix CT is an alternative option if treatments such as tranexamic acid, hormonal contraceptives, and intrauterine delivery systems have not worked or are unsuitable,' it said. 'Relugolix CT is currently the only licensed GnRH antagonist option and is an alternative secondary medical option to GnRH agonists (eg Prostap & Zoladex) which are only licensed for up to six months. Relugolix CT can be taken up until menopause.' The watchdog initially rejected the drug, but new evidence was provided by Gedeon Richter, its manufacturer, to address questions about effectiveness and value for money. Helen Knight, the director of medicines evaluation at Nice, said: 'This new treatment marks a potential step-change in how we manage endometriosis, putting control back in patients' hands while ensuring value for the taxpayer. 'Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home. 'The treatment can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side-effects. 'This convenience not only benefits patients but reduces pressure on NHS services.' The list price for the treatment is £72 for a 28-day supply (excluding VAT). Diagnosis of endometriosis typically takes nine years from when symptoms first appear, according to Nice. The NHS says it can take a long time to diagnose because symptoms can be similar to other conditions, such as fibroids, pelvic inflammatory disease and irritable bowel syndrome.
The Independent
13-03-2025
- Health
- The Independent
New pill to transform treatment of endometriosis approved on the NHS
A new pill designed to transform the treatment of endometriosis has been approved for use on the NHS. The combination drug could help around 1,000 women every year in England who suffer from the debilitating condition. The drug that has been approved by the National Institute for Health and Care Excellence (Nice) is called relugolix–estradiol–norethisterone (also known as relugolix combination therapy or Ryeqo). This is the first long-term daily pill licensed to treat the condition, and works by blocking specific hormones that contribute to endometriosis, while also providing necessary hormone replacement. Unlike current injectable treatments which can initially worsen symptoms, the pill can be taken at home, works more quickly, combines hormones in one pill and cuts the need for visits to clinics. Endometriosis occurs when cells similar to those in the lining of the womb grow in other parts of the body, such as the pelvis, bladder and bowel. It can cause severe pain, heavy periods, exhaustion and fertility problems and can have a big impact on women's lives. Endometriosis affects around 1.5 million women in the UK but, according to Nice, diagnosis typically takes nine years from when symptoms first appear. Nice initially rejected the drug, but new evidence was provided by the manufacturer Gedeon Richter to address questions about effectiveness and value for money. The drug will only be made available on the NHS for patients whose medical or surgical treatment for endometriosis has failed. Helen Knight, director of medicines evaluation at Nice, said: 'This new treatment marks a potential step-change in how we manage endometriosis, putting control back in patients' hands while ensuring value for the taxpayer. 'Instead of travelling to clinics for injections, there is now a daily tablet that can be taken at home. 'The treatment can also be stopped and started more easily, which is particularly important for those planning to have children and for managing side-effects. 'This convenience not only benefits patients but reduces pressure on NHS services.' The list price for the treatment is £72 for a 28-day supply (excluding VAT). According to the NHS website, it can take a long time to diagnose endometriosis because symptoms can be similar to other conditions, such as fibroids, pelvic inflammatory disease and irritable bowel syndrome. The charity Endometriosis UK said it noted the drug may be suitable for only a small proportion of the 1.5 million women with the disease. 'For those with a history of previous medical or surgical treatment for their endometriosis, Relugolix CT is an alternative option if treatments such as tranexamic acid, hormonal contraceptives, and intrauterine delivery systems have not worked or are unsuitable,' it said in a statement. 'Relugolix CT is currently the only licensed GnRH antagonist option and is an alternative secondary medical option to GnRH agonists (eg Prostap & Zoladex) which are only licensed for up to six months. 'Relugolix CT can be taken up until menopause.' Dr Sue Mann, NHS national clinical director for women's health, said: 'This first-of-a-kind treatment for endometriosis – a condition which can be extremely debilitating – will give women greater control of their own health by potentially allowing them to get the treatment they need in the comfort of their own homes, without the need to attend regular appointments.'
