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September 2025
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Human Medicines Highlights
The newsletter for patients, consumers and
healthcare professionals
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In this issue
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Welcome to the September 2025 issue of the Human Medicines Highlights newsletter, the monthly newsletter published by the European Medicines Agency specifically for patients, consumers, healthcare professionals and their representative organisations.
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Highlights from the September meeting of the CHMP includea positive recommendation for Uplizna (inebilizumab) to treat active immunoglobulin G4-related disease (IgG4-RD), a rare chronic autoimmune disease for which there is currently no treatment authorised in the EU.
Earlier this week, EMA has issued a statement on paracetamol to emphasise that its use during pregnancy remains unchanged in the EU. There is currently no new evidence that would require changes to the current EU recommendations for use. EMA’s safety committee (PRAC) has also started a review of medicines containing levamisole, authorised in Hungary, Lithuania, Latvia and Romania to treat infections caused by parasitic worms in adults and children.
EMA and the Heads of Medicines Agencies (HMA) are warning the public about the growing threat of illegal medicines being advertised for weight loss and diabetes. Such illegal products pose a serious risk to public health as they may not contain the claimed active substance and may contain harmful substances.
As you know, EMA is heavily regulated and patients, consumers and HCP experts involved in our activities must comply with the Agency’s competing interests policy. To help with the completion of declarations of interest when needed, we have developed a short guide that is now available on our website. We hope this will make it easier for experts to understand EMA’s requirements.
In global news, EMA and the World Health Organization (WHO) are celebrating a decade of formal collaboration and shared commitment to address global health challenges. Since 2015 this partnership has focused on cooperation on scientific evaluation and regulatory capacity-building for improving public health worldwide.
Last but not least, I am happy to let you know that the Patients and Consumers’ and Healthcare Professionals’ Working Parties both elected 2 new Co-Chairs in this week’s meeting.
I hope you enjoy reading this issue of our newsletter. Please feel free to share it with your members and networks. As always, we welcome your feedback and suggestions for future issues. Please share this with us by email: public-engagement@ema.europa.eu.
Juan Garcia Burgos
Head of Public and Stakeholder Engagement
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EMA news
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Information on medicines
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Anti-infectives
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Supply shortages
- Biltricide (praziquantel)
Treatment of infections caused by trematodes (parasitic worms).
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Cancer
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New medicines recommended for approval
- Degevma (denosumab) biosimilar
treatment of giant cell tumour of bone and prevention of bone complications with advanced cancer involving bone
New medicines recommended for approval
- Lynkuet (elinzanetant)
Treatment of vasomotor symptoms (hot flushes)
New medicines recommended for approval
- Zvogra (denosumab) biosimilar
Prevention of of bone complications with cancer involving bone and treatment of giant cell tumour of bone
New information on approved medicines
- Keytruda (pembrolizumab) - new indication
Treatment of several types of cancer
New information on approved medicines
- Keytruda (pembrolizumab) - new pharmaceutical form
Treatment of several types of cancer
New information on approved medicines
- Lunsumio (mosunetuzumab)- new route of administration / new pharmaceutical form / new strengths
Treatment of follicular lymphoma (a type of blood cancer)
New information on approved medicines
- Lutathera (lutetium (177Lu) oxodotreotide)
Outcome of assessment on use of Lutathera in treatment of gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs) in adolescents: Although EMA did not recommend this use, it agreed that relevant data from the study submitted with the application be included in the medicine’s product information so that healthcare professionals have access to up-to-date data on the effects of Lutathera in people with GEP-NETs
Withdrawal of applications for new medicines
- Amtagvi (lifileucel)
Treatment of melanoma (skin cancer)
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Cardiovascular system
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New medicines recommended for approval
- Rivaroxaban Koanaa (rivaroxaban) generic
Prevention of venous thromboembolism, the treatment and prevention of deep vein thrombosis and pulmonary embolism, and the prevention of stroke and systemic embolism
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Dermatology
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New medicines recommended for approval
- Gobivaz (golimumab) biosimilar
Treatment of rheumatoid arthritis (a disease causing inflammation of the joints), juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints), psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints), axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine) and ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding)
New medicines recommended for approval
- Usgena (denosumab) biosimilar
Treatment of plaque psoriasis (a disease causing red, scaly patches on the skin), psoriatic arthritis (inflammation of the joints associated with psoriasis), Crohn’s disease (a disease-causing inflammation of the gut) and ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding)
New information on approved medicines
- Dupixent (dupilumab) - new indication
Treatment of atopic dermatitis (also known as atopic eczema, when the skin is itchy, red and dry), severe asthma, chronic obstructive pulmonary disease (a long-term disease that causes breathing difficulties due to airway obstruction and damage to the lung), inflammation of the nose and sinuses together with growths (polyps), prurigo nodularis (a long-term skin disease with a rash causing lumps with intense itching), eosinophilic oesophagitis (an allergic inflammatory condition of the foodpipe), and spontaneous urticaria (itchy rash)
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Gastro-intestinal system
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New medicines recommended for approval
- Gobivaz (golimumab) biosimilar
Treatment of rheumatoid arthritis (a disease causing inflammation of the joints), juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints), psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints), axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine) and ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding)
New medicines recommended for approval
- Usgena (denosumab) biosimilar
Treatment of plaque psoriasis (a disease causing red, scaly patches on the skin), psoriatic arthritis (inflammation of the joints associated with psoriasis), Crohn’s disease (a disease-causing inflammation of the gut) and ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding)
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Gynaecology & Obstetrics
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New medicines recommended for approval
- Lynkuet (elinzanetant)
Treatment of vasomotor symptoms (hot flushes)
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Diabetes
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New medicines recommended for approval
- Kyinsu (insulin icodec / semaglutide)
Treatment of diabetes
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Haematology
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Withdrawal of applications for new medicines
- Fanskya (mozafancogene autotemcel)
Treatment of fanconi anaemia type A, an inherited condition that affects the bone marrow, the spongy tissue inside the large bones where blood cells are made
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HIV
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New information on approved medicines
- Norvir (ritonavir) - change of indication
Given together with other HIV medicines called protease inhibitors to enhance their activity in the treatment of human immunodeficiency virus-1 (HIV-1)
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Immune system
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New information on approved medicines
- Uplizna (inebilizumab) – new indication
Treatment of immunoglobulin G4-related disease (an autoimmune condition that can cause tissue scarring (fibrosis)) and neuromyelitis optica spectrum disorders (inflammatory disorders that affect mainly the optic nerve, which connects the eye to the brain, and the spinal cord)
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Nervous system
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New medicines recommended for approval
- Imaavy (nipocalimab)
Treatment of generalised myasthenia gravis (a disease that leads to muscle weakness and tiredness)
New information on approved medicines
- Koselugo (selumetinib) - change of indication
Treatment of plexiform neurofibromas (benign non-cancerous tumours along the nerves)
Withdrawal of applications for new medicines
- Tuzodi (midazolam)
Treatment of seizures
Direct Healthcare Professional Communication (DHPC)
- Clozapine (clozapine)
Treatment of schizophrenia
Direct Healthcare Professional Communication (DHPC)
- Evrysdi (risdiplam)
Treatment of 5q spinal muscular atrophy (a genetic disease that causes weakness and wasting of the muscles including the lung muscles)
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Respiratory system
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New medicines recommended for approval
- Enflonsia (clesrovimab)
Prevention of RSV lower respiratory tract disease
New information on approved medicines
- Bimervax (COVID-19 vaccine) – extension of indication
Prevention of COVID-19
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Rheumatology
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New medicines recommended for approval
- Acvybra (denosumab) biosimilar
Treatment of osteoporosis (a disease that makes bones fragile) and bone loss
New medicines recommended for approval
- Denosumab Intas (denosumab) biosimilar
Treatment of osteoporosis (a disease that makes bones fragile) and bone loss
New medicines recommended for approval
- Gobivaz (golimumab) biosimilar
Treatment of rheumatoid arthritis (a disease causing inflammation of the joints), juvenile idiopathic arthritis (a rare childhood disease causing inflammation of many joints), psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints), axial spondyloarthritis (a disease causing inflammation and pain in the joints of the spine) and ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding)
New medicines recommended for approval
- Kefdensis (denosumab) biosimilar
Treatment of osteoporosis (a disease that makes bones fragile) and bone loss
New medicines recommended for approval
- Ponlimsi (denosumab) biosimilar
Treatment of osteoporosis (a disease that makes bones fragile) and bone loss
New medicines recommended for approval
- Usgena (denosumab) biosimilar
Treatment of plaque psoriasis (a disease causing red, scaly patches on the skin), psoriatic arthritis (inflammation of the joints associated with psoriasis), Crohn’s disease (a disease-causing inflammation of the gut) and ulcerative colitis (inflammation of the large intestine causing ulceration and bleeding)
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Vaccines
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New information on approved medicines
- Bimervax (COVID-19 vaccine) – extension of indication
Prevention of COVID-19
Direct Healthcare Professional Communication (DHPC)
- Ixchiq (clozapine)
Prevention of disease caused by the chikungunya virus
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Other medicines
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Withdrawal of applications for new medicines
- Omforro (midazolam)
Sedation before and during diagnostic or therapeutic procedures where the patient remains awake (conscious sedation), or as premedication before anaesthesia
Direct Healthcare Professional Communication (DHPC)
- Rapamune (sirolimus)
Prevention of the body from rejecting a newly transplanted kidney
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Recent events
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Cancer Medicines Forum - minutes published
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The summary and minutes of the June Cancer Medicines Forum are available on the event page.
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Upcoming events
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Workshop on the use of external controls for evidence generation in regulatory decision-making
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The EMA Methodology Working Party is holding a hybrid workshop to engage with stakeholders on the use of external controls. Registration is open until 17 October 2025.
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03/11/2025
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Public webinar: Shortages - putting patients first
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Join our webinar on 4 November to learn what EMA and the EU network are doing to manage medicine shortages. The webinar will also discuss what patients, consumers and healthcare professionals can do to prepare for and help manage these shortages. No registration is needed for the live stream.
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Annual open meeting of the European Network of Paediatric Research at EMA (Enpr-EMA)
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Enpr-EMA’s annual meeting is an opportunity for stakeholders in the field of paediatric clinical trials (such as healthcare professionals, parents, carers and patient representatives) to learn about the network’s activities. Registration is open until 31 October 2025.
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20/11/2025
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Amsterdam and online
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HMA/EMA multistakeholder workshop on artificial intelligence
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This workshop will discuss the state of the art in AI and HMA/EMA activities in the field. Registration for virtual attendance is open until 2 November and the event will also be broadcast live.
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20/11/2025 - 21/11/2025
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EMA/HMA Annual Data Forum
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This annual event, coordinated by the Network Data Steering Group, will offer an opportunity for regulators and stakeholders across the EU to share progress and insights on data-related activities.
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Multistakeholder workshop on patient registries for Alzheimer's disease
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This hybrid HMA/EMA workshop aims to facilitate long-term follow up of medicines for Alzheimer's disease using patient registries. Registration for active participation online is possible until 2 November and the event will also be broadcast live.
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15/12/2025
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Open consultations
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- Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects
Deadline for comments: 30 September 2025
- Concept paper on the new reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis
Deadline for comments: 30 September 2025
- Guideline on the quality aspects of mRNA vaccines
Deadline for comments: 30 September 2025
- Reflection paper on a tailored clinical approach in biosimilar development
Deadline for comments: 30 September 2025
- Concept paper on the development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making
Deadline for comments: 31 October 2025
- ICH E20 Guideline on adaptive designs for clinical trials - step 2b
Deadline for comments: 30 November 2025
- Concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease
Deadline for comments: 28 February 2026
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Scientific committee and working party activities
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EMA publications
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Quick guide to competing interests for patient and healthcare professional experts
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This new quick guide provides an overview of which interests you are expected to declare as an EMA expert and the impact of the declared interests. It contains links to the relevant EMA policy and procedural guidance and should be read together with those documents.
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Feedback from EMA to the European Commission on alternatives to replace titanium dioxide in medicinal products
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EU regulatory experts have concluded that, should an alternative for titanium dioxide in medicines be identified, a transition period of more than 12 years would be required to allow the use of titanium dioxide in medicines to be phased out.
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How EMA involves stakeholders
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Public call for expression of interest for experts to become members of EMA's scientific advisory group on immune and inflammatory diseases
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EMA is inviting applications from interested experts with clinical/technical expertise for appointment as
core members of the scientific advisory group (SAG) on immune and inflammatory diseases. The call is open until 17 October 2025.
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From lab to patient: the journey of a centrally authorised medicine
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Follow the journey of a centrally authorised medicine: find out what happens at every stage and how stakeholders are involved. An interactive timeline is available in English and the PDF leaflet can be consulted in 22 European languages
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ISSN: 2811-9649
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Catalogue Number: TC-01-25-048-EN-Q
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