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July 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 July 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. This month, we bring you updates from a multistakeholder workshop on GLP-1 medicines and the new recommendations for managing shortages of these medicines.
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You can also read about EMA’s engagement with healthcare professionals, its origins, and how it has evolved over the years.
In other news, the clinical trials initiative ACT EU has launched two pilots offering early advice to medicine developers that can help enhance the quality of applications for clinical trials. A new version of CTIS, the clinical trials information portal, has been launched providing earlier access to important information about clinical trials. Last, the PRAC, EMA's safety committee, elected a new Chair.
I hope you enjoy reading the Human Medicines Highlights. Please feel free to share it with your members and networks, who will be able to read the online version of the newsletter in their own language.
We welcome your feedback and suggestions for future issues. Please share this with us: 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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Antivirals/anti-infectives
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New information on authorised medicines
- Cresemba (isavuconazole) - extension of indication - orphan
Treatment of fungal infections: invasive aspergillosis and mucormycosis
- Pegasys (peginterferon alfa-2a) - extension of indication
Treatment of polycythaemia vera (blood disease leading to production of too many red blood cells), essential thrombocythaemia (too many platelets in the blood), chronic hepatitis B and C
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Cancer
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Positive CHMP opinions on new medicines
- Balversa (erdafitinib)
Treatment of urothelial carcinoma (a type of cancer that usually begins in the cells lining the bladder)
- Enzalutamide Viatris (enzalutamide) generic
Treatment of prostate cancer
- Nilotinib Accord (nilotinib) generic
Treatment of chronic myelogenous leukaemia (blood cancer)
- Ordspono (odronextamab) orphan
Treatment of different kind of blood cancers
New information on authorised medicines
- Imfinzi (durvalumab) - new indication
Treatment of different kind of cancers
- Lynparza (olaparib) - new indication
Treatment of different kind of cancers
- Tepkinly (epcoritamab) - new indication - orphan - conditional approval
Treatment of lymphoma and large B-cell cancer (blood cancers)
- Xalkori (crizotinib) - extension of indication
Treatment of non-small cell lung cancer
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Cardiovascular system
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Positive CHMP opinions on new medicines
- Winrevair (sotatercept) orphan
Treatment of pulmonary arterial hypertension (high blood pressure in the lungs)
Withdrawal of applications for new medicines
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Dermatology
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Positive CHMP opinions on new medicines
- Steqeyma (ustekinumab) biosimilar
Treatment of plaque psoriasis (scaly patches on skin), psoriatic arthritis (joint inflammation with psoriasis) and Crohn’s disease (an inflammatory disease affecting the gut)
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Diabetes
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New information on authorised medicines
- Vabysmo (faricimab) - extension of indication
Treatment of conditions affecting the macula (the central part of the retina at the back of the eye), including diabetic complications
Supply shortages
- Saxenda (liraglutide)
Treatment of type 2 diabetes and obesity
- Trulicity (dulaglutide)
Treatment of type 2 diabetes
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Gynaecology & Obstetrics
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Supply shortages
- Menopur (menotropin)
Treatment of female and male infertility disorders
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Haematology
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Positive CHMP opinions on new medicines
- Piasky (crovalimab)
Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells)
New medicines authorised
- Fabhalta (Iptacopan) orphan
Treatment of paroxysmal nocturnal haemoglobinuria (a condition in which there is excessive breakdown of red blood cells), thrombosis (blood clots in blood vessels), pancytopenia (low levels of blood cells) and dark urine (due to large amounts of haemoglobin being released into the urine)
New information on authorised medicines
- Pegasys (peginterferon alfa-2a) - extension of indication
Treatment of polycythaemia vera (blood disease leading to production of too many red blood cells), essential thrombocythaemia (too many platelets in the blood), chronic hepatitis B and C
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Immune system
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Positive CHMP opinions on new medicines
- Eurneffy (epinephrine)
Treatment of allergic reactions (anaphylaxis)
- Steqeyma (ustekinumab) biosimilar
Treatment of plaque psoriasis (scaly patches on skin), psoriatic arthritis (joint inflammation with psoriasis) and Crohn’s disease (an inflammatory disease affecting the gut)
Withdrawal of authorised medicines
- Ocaliva (obeticholic acid)
Treatment of primary biliary cholangitis (an autoimmune disease in which there is gradual destruction of the bile ducts in the liver)
Supply shortages
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Ophthalmology
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Negative CHMP opinions on new medicines
- Syfovre (pegcetacoplan)
Intended for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration
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Nervous system
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Positive CHMP opinions on new medicines
- Tauvid (flortaucipir (18F))
intended for the diagnosis of Alzheimer’s disease
New medicines authorised
- Qalsody (tofersen) orphan - exceptional circumstances
Treatment of amyotrophic lateral sclerosis (progressive disease of the nervous system)
Negative CHMP opinions on new medicines
- Masitinib AB Science (masitinib)
Intended for the treatment of amyotrophic lateral sclerosis (progressive disease of the nervous system)
- Translarna (ataluren)
Intended for treatment of Duchenne muscular dystrophy (genetic disease that gradually causes weakness and loss of muscle function)
Supply shortages
- Zypadhera (olanzapine)
Treatment of schizophrenia
Direct Healthcare Professional Communication (DHPC)
- Zypadhera (olanzapine pamoate monohydrate)
Treatment of schizophrenia
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Ophthalmology
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New information on authorised medicines
- Vabysmo (faricimab) - extension of indication
Treatment of conditions affecting the macula (the central part of the retina at the back of the eye), including diabetic complications
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Respiratory system
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Positive CHMP opinions on new medicines
- mResvia (Single-stranded 5' capped mRNA encoding the Respiratory syncytial virus glycoprotein F stabilized in the prefusion conformation)
Prevention of lower respiratory tract disease caused by respiratory syncytial virus
New information on authorised medicines
- Beyfortus (nirsevimab) - new extension of indication
Prevention of serious lower respiratory tract (lung) disease caused by respiratory syncytial virus
Supply shortages
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Rheumatology
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Positive CHMP opinions on new medicines
- Steqeyma (ustekinumab) biosimilar
Treatment of plaque psoriasis (scaly patches on skin), psoriatic arthritis (joint inflammation with psoriasis) and Crohn’s disease (an inflammatory disease affecting the gut)
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Urology
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New information on authorised medicines
- Betmiga (mirabegron)- new indication
Treatment of overactive bladder syndrome
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Vaccines
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New information on authorised medicines
- Infanrix Hexa (diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)) – change of indication
Prevention of different kind of diseases
Product update
- Review of Havrix (hepatitis A virus (inactivated, adsorbed)) - CHMP Opinion
Prevention of hepatitis A virus
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Other medicines
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New information on authorised medicines
- Imcivree (setmelanotide) – extension of indication - orphan
Treatment of obesity and control of hunger associated with different syndromes
Supply shortages
- Saxenda (liraglutide)
Treatment of type 2 diabetes and obesity
Safety update
Product update
- Review of Lorazepam Macure 4 mg/ml, solution for injection - CHMP Opinion
Sedative before surgery or extensive physical examinations
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Upcoming events
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Multi-stakeholder workshop on pharmacogenomics
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A multi-stakeholder workshop on pharmacogenomics will take place on 24 September 2024. The outcomes will inform a roadmap towards clinical implementation of pharmacogenomics in Europe. Visit the event page for more information and to register.
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date |
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24/09/2024
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venue |
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EMA and online
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Fifth EMA/HMA Big Data Stakeholder Forum
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The Big Data Stakeholder Forum will reflect on the accelerating journey towards data-driven medicines regulation, consider data-enabled opportunities to improve medicines development in the EU and discuss how to strengthen collaboration with stakeholders. Please consult the event page for more information.
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date |
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28/11/2024
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Recent events
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Multistakeholder workshop on shortages of GLP-1 receptor agonists: presentations published
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EMA has published the presentations from this workshop held on 1 July 2024 on the event page.
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HMA/EMA workshop on real-world evidence methods: recording published
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The video recording of this workshop, which took place on 14 June 2024, is now available on the event page.
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EMA workshop on haemoglobinopathies: presentations published
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Presentations from the workshop on haemoglobinopathies, held on 1 July 2024, are available on the event page.
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Open consultations
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- 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
- Concept paper on the revision of the COVID-19 vaccines guidance to CHMP
Deadline for comments: 30 September 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-24-003-EN-Q
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