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June 2024
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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 June 2024 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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This month, we bring you important updates on medicines, including the re-evaluation of Translarna, a medicine for Duchenne muscular dystrophy, and the suspension of hydroxyprogesterone caproate medicines, used for prevention of premature birth, from the EU market.
In other news, the World Health Organization has designated the European medicines regulatory network as a listed authority, recognising that it meets international regulatory standards. And a joint framework for action has just been published by the relevant EU agencies to strengthen cooperation and support implementation of the One Health approach in the European Union.
We also invite you to take a look at our recently published Annual Report 2023, which contains a wealth of information and key figures on EMA’s contribution to public health in the EU.
Finally, as a reminder, do not forget to reply to the EMA’s 2024 communication perception survey! The survey is still open until 21 June.
I hope you enjoy reading the Human Medicines Highlights. Please feel free to share it with your members and networks, especially since the online version of the newsletter is now available in all EU languages, which will help bring the content to more readers.
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-virals / anti-infectives
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Positive CHMP opinions on new medicines
- Fluenz (influenza vaccine (live attenuated, nasal))
Prevention of influenza disease
- Ixchiq (Chikungunya vaccine (live))
Prevention of chikungunya disease
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Cancer
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Positive CHMP opinions on new medicines
- Apexelsin (paclitaxel) generic of Abraxane
Treatment of breast cancer, adenocarcinoma of the pancreas and non-small cell lung cancer
- Avzivi (bevacizumab) biosimilar
Treatment of different kinds of cancer
- Cejemly (sugemalimab)
Treatment of metastatic non-small cell lung cancer in combination with chemotherapy
- Dasatinib Accord Healthcare (dasatinib) generic of Sprycel
Treatment of chronic myelogenous leukaemia, a type of blood cancer
- Pomalidomide Accord (pomalidomide) generic of Imnovid
Treatment of multiple myeloma, cancer of the bone marrow
- Pomalidomide Zentiva (pomalidomide) generic of Imnovid
Treatment of multiple myeloma, cancer of the bone marrow
New information on authorised medicines
- Tagrisso (osimertinib) - new indication
Treatment of different types of cancer
- Tevimbra (tislelizumab) - new indication
Treatment of non-small cell lung cancer and oesophageal squamous cell carcinoma, a cancer of the food pipe
Safety update
- CAR T-cell medicines (Yescarta, Tecartus, Carvykti, Abecma, Breyanzi, Kymriah) - PRAC recommendation
Personalised treatment for different types of blood cancer that uses a patient’s own white blood cells (T-cells) to attack the cancer
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Cardiovascular system
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New information on authorised medicines
- Eliquis (apixaban) - extension of indication
Treatment of venous thromboembolism (blood clots)
Withdrawal of applications for new medicines
- Kinharto (Omecamtiv mecarbil)
Intended to treat heart failure
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Dermatology (skin conditions)
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New information on authorised medicines
- Dupixent (dupilumab) - new indication
Treatment of an inflammatory condition affecting the food pipe, atopic dermatitis (inflammation of the skin) and chronic obstructive pulmonary disease (a lung condition)
- Skyrizi (risankizumab) - new indication
Treatment of plaque psoriasis (scaly patches on skin), psoriatic arthritis and ulcerative colitis (an inflammatory disorder of the gut)
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Diabetes
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Positive CHMP opinions on new medicines
- Zegalogue (dasiglucagon)
Treatment of diabetes mellitus
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Gastro-intestinal system
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New information on authorised medicines
- Skyrizi (risankizumab) - new indication
Treatment of plaque psoriasis (scaly patches on skin), psoriatic arthritis and ulcerative colitis (an inflammatory disorder of the gut)
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Haematology
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Positive CHMP opinions on new medicines
- Durveqtix (fidanacogene elaparvovec)
Treatment of haemophilia B
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Immune system
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Positive CHMP opinions on new medicines
- Adzynma (rADAMTS13) exceptional circumstances
Treatment of congenital thrombotic thrombocytopenic purpura (a blood clotting disorder)
New information on authorised medicines
- Dupixent (dupilumab) - new indication
See Dermatology section above
- Skyrizi (risankizumab) - new indication
Treatment of plaque psoriasis (scaly patches on skin), psoriatic arthritis and ulcerative colitis (an inflammatory disorder of the gut)
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Nephrology
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New information on authorised medicines
- Kinpeygo (budesonide) - extension of indication - conditional approval - orphan medicine
Treatment of immunoglobulin A nephropathy, a disease where the kidneys gradually stop working and eventually fail
- Livmarli (Maralixibat chloride) - new indication – orphan medicine
Treatment of cholestatic liver diseases (diseases in which bile cannot drain properly from the liver)
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Nervous system
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Negative CHMP opinions on extension of indication
- Valdoxan (Agomelatine)
Treatment of depression
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Ophthalmology (eye conditions)
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Positive CHMP opinions on new medicines
- Akantior (polihexanide) orphan medicine
Treatment of Acanthamoeba keratitis, a severe, progressive and sight threatening corneal infection, (a rare serious infection of the eye)
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Respiratory system
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New information on authorised medicines
- Dupixent (dupilumab) - new indication
Treatment of an inflammatory condition affecting the food pipe, atopic dermatitis (inflammation of the skin) and chronic obstructive pulmonary disease (a lung condition)
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Rheumatology
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New information on authorised medicines
- Skyrizi (risankizumab) - new indication
Treatment of plaque psoriasis (scaly patches on skin), psoriatic arthritis and ulcerative colitis (an inflammatory disorder of the gut)
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Vaccines
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Positive CHMP opinions on new medicines
- Fluenz (influenza vaccine (live attenuated, nasal))
Prevention of influenza disease
- Ixchiq (Chikungunya vaccine (live))
Prevention of chikungunya disease
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Other medicines
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Positive CHMP opinions on new medicines
- GalliaPharm (Gallium (68Ga) chloride / Germanium (68Ge) chloride)
Radionuclide generator intended for radiolabelling products used during body scans
Withdrawal of applications for extension of indication
- Scenesse (afamelanotide) orphan medicine, exceptional circumstances
Treatment of erythropoietic protoporphyria (EPP), a rare disease that causes intolerance to light
Safety update
- Review of metamizole containing medicines - review started
Treatment of pain following surgery or injuries to the treatment of cancer-related pain and fever
Direct Healthcare Professional Communication (DHPC)
- Giapreza (angiotensin II)
Treatment of very low blood pressure (a condition known as shock)
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Upcoming events
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Multistakeholder workshop on shortages of Glucagon-Like Peptide-1 (GLP-1) receptor agonists
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This multistakeholder workshop is by invitation only, those interested in following the live broadcast can do so on the day through the linked event page.
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01/07/2024
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Patient and Consumer Working Party & Healthcare Professionals Working Party joint meeting
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The EMA Patients and Consumers Working Party (PCWP) and Healthcare Professionals Working Party (HCPWP) will hold their separate and joint plenary meetings on 2-3 July 2024.
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02/07/2024 - 03/07/2024
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Recent events
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Meeting report of the joint EMA/EORTC workshop on soft tissue and bone sarcomas
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We have published the joint EMA/EORTC workshop report on soft tissue and bone sarcomas, reflecting on how to develop new treatments in ultra-rare sarcomas as a model for ultra-rare tumours.
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Open consultations
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- Revised HMA/EMA guidance on identification of commercially confidential information and personal data in the structure of marketing authorisation application dossiers
Deadline for comments: 28 June 2024
- ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines
Deadline for comments: 30 August 2024
- Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence
Deadline for comments: 31 August 2024
- Guideline on requirements for demonstrating therapeutic equivalence between orally inhaled products for asthma and COPD
Deadline for comments: 30 October 2024
- Guideline on pharmaceutical quality of inhalation and nasal medicinal products
Deadline for comments: 31 October 2024
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Scientific committee and working party activities
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EMA publications
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How EMA involves stakeholders
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ISSN: 2811-9649
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Catalogue Number: TC-AN-24-002-EN-Q
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