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January 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 January 2025 issue of Human Medicines Highlights, EMA's monthly newsletter for patients, consumers, healthcare professionals and their representative organisations. I hope you have had a relaxing winter break, and this finds you in fine form to embrace 2025.
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In this issue, you will find recent updates on medicines regulation as well as other news and the usual section on dedicated medicines.
EMA and the Heads of Medicines Agencies have carried out a comprehensive overhaul of guidance on the identification of commercially confidential information (CCI) and personal data in marketing authorisation applications for human medicines, reaffirming our commitment to transparency. The revised guidance is now available on our website.
The EU regulation on health technology assessment became applicable on 12 January 2025 and EMA will support its implementation, particularly in the conduct of joint clinical assessments, joint scientific consultations and horizon scanning.
the revised versions of our policies on the handling of competing interests of scientific committee members and experts (‘Policy 0044’) and of the EMA Management Board members (‘Policy 0058’).
A pilot exploring the creation and testing of electronic product information (ePI) has found that the EU regulatory system is prepared for ePI while there is a need for more development. Work to endorse this new practice will continue this year.
everal first treatments have been recommended for marketing authorisation: Emcitate (tiratricol) for Allan-Herndon-Dudley syndrome, and Welireg (belzutifan) for von Hippel-Lindau disease and advanced kidney cancer. EMA has also recommended extending the indication of Ofev (nintedanib) to include the fibrosing interstitial lung diseases in children and adolescents, for whom approved treatments have not existed. On the other hand, Alofisel, for the treatment of Chrohn’s disease, has been found not to be beneficial and will be withdrawn.
look forward to another year of fruitful collaboration and, as always, encourage you to share this newsletter with your members and networks. Your feedback and suggestions for future issues help us maintain the focus of this newsletter on what matter to you most. Please send any thoughts you have to: 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 approved medicines
- Flucelvax Tetra (influenza vaccine (surface antigen, inactivated, prepared in cell cultures)) - extension of indication
Prevention of flu
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Cancer
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New medicines recommended for approval
- Osenvelt (denosumab) biosimilar
Prevention of complications with advanced bone cancer and for the treatment of giant cell tumour of bone (a type of bone cancer)
- Welireg (tiratricol)
Treatment of advanced kidney cancer and treatment of cancers in patients with von Hippel-Lindau (VHL) disease
- Zefylti (filgrastim) biosimilar
Treatment of neutropenia (low level of white blood cells) in patients having chemotherapy or a bone marrow transplant
New information on approved medicines
- Blincyto (blinatumomab) - extension of indication
Treatment of B-precursor acute lymphoblastic leukaemia (a type of blood cancer)
New information on approved medicines
- Jemperli (dostarlimab)- extension of indication
Treatment of several types of cancer
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Cardiovascular system
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New medicines recommended for approval
- Beyonttra (acoramidis)
Treatment of wild-type or variant transthyretin amyloidosis (a condition affecting the heart muscle) in patients with cardiomyopathy (ATTR-CM)
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Dermatology
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New medicines recommended for approval
- Nemluvio (nemolizumab)
Treatment of atopic dermatitis (condition causing itchy, red and dry skin) and prurigo nodularis (a condition causing nodes on the skin)
- Yesintek (ustekinumab) biosimilar
Treatment of plaque psoriasis (scaly patches on skin), psoriatic arthritis, and Crohn's disease (an inflammatory condition of the gut)
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Gastro-intestinal system
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New medicines recommended for approval
- Yesintek (ustekinumab) biosimilar
Treatment of plaque psoriasis (scaly patches on skin), psoriatic arthritis, and Crohn's disease (an inflammatory condition of the gut)
New information on approved medicines
- Omvoh (mirikizumab) - extension of indication
Treatment of ulcerative colitis (a disease causing inflammation and ulcers in the lining of the bowel) or Crohn’s disease (a disease causing inflammation of the digestive tract)
Direct Healthcare Professional Communication (DHPC)
- Alofisel (levetiracetam)
Treatment of Crohn’s disease (an inflammatory condition of the gut)
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Haematology
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New medicines recommended for approval
- Rytelo (imetelstat sodium) orphan
Treatment of anaemia (low levels of red blood cells)
- Zefylti (filgrastim) biosimilar
Treatment of neutropenia (low level of white blood cells) in patients having chemotherapy or a bone marrow transplant
Direct Healthcare Professional Communication (DHPC)
- Medroxyprogesterone acetate (medroxyprogesterone acetate)
Gynaecological (including contraception and endometriosis) and oncological indications
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HIV
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New information on approved medicines
- Rekambys (rilpivirine) - extension of indication
Treatment of human immunodeficiency virus type 1 (HIV‑1) infection
- Vocabria (cabotegravir) - extension of indication
Treatment of Human Immunodeficiency virus type 1 (HIV-1) infection
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Immune system
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New medicines recommended for approval
- Andembry (garadacimab)
Routine prevention of attacks of hereditary angioedema (swelling)
- Avtozma (tocilizumab)
Treatment of rheumatoid arthritis
- Yesintek (ustekinumab) biosimilar
Treatment of plaque psoriasis (scaly patches on skin), psoriatic arthritis, and Crohn's disease (an inflammatory disease of the gut)
New information on approved medicines
- Omvoh (mirikizumab) - extension of indication
Treatment of ulcerative colitis (a disease causing inflammation and ulcers in the lining of the bowel) or Crohn’s disease (a disease causing inflammation of the digestive tract)
Direct Healthcare Professional Communication (DHPC)
- Alofisel (levetiracetam)
Treatment of Crohn’s disease (an inflammatory disease of the gut)
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Liver conditions
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New medicines recommended for approval
- Seladelpar Gilead (seladelpar lysine dihydrate) orphan
Treatment of primary biliary cholangitis
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Nervous system
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New medicines recommended for approval
- Emcitate (tiratricol) orphan
Treatment of abnormal thyroid hormone levels in patients with Allan-Hernon-Dudley syndrome (a brain condition)
Direct Healthcare Professional Communication (DHPC)
- Keppra (levetiracetam)
Treatment of seizures
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Respiratory system
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New medicines recommended for approval
- Kavigale (sipavibart)
Prevention of COVID-19
- Kostaive (zapomeran)
Prevention of COVID-19
New information on approved medicines
- Ofev (nintedanib) - extension of indication
Treatment of diseases involving scarring of the lungs
Supply shortages
- Salbutamol inhalation products (salbutamol)
Treatment of breathing problems in people with asthma, chronic obstructive pulmonary (lung) disease (COPD) and similar conditions
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Vaccines
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New medicines recommended for approval
- Kavigale (sipavibart)
Prevention of COVID-19
- Kostaive (zapomeran)
Prevention of COVID-19
New information on approved medicines
- Flucelvax Tetra (influenza vaccine (surface antigen, inactivated, prepared in cell cultures)) - extension of indication
Prevention of flu
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Other medicines
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New medicines recommended for approval
- Paxneury (guanfacine) generic
Treatment of attention deficit hyperactivity disorder (ADHD)
- Tuzulby (methylphenidate hydrochloride) biosimilar
Treatment of attention deficit hyperactivity disorder (ADHD)
New information on approved medicines
- Bridion (sugammadex) - extension of indication
Reversal of the effects of rocuronium, a muscle relaxant used in operations
Supply shortages
- Cyanokit (hydroxocobalamin)
Treatment of known or suspected poisoning with cyanide
Supply shortages
- Norditropin NordiFlex (somatropin)
Promotion of growth in people with growth hormone deficiency and those with growth problems
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Recent events
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Cancer Medicines Forum, October 2024: minutes and presentation
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The minutes and presentation from The Cancer Medicines Forum held on 1 October 2024 have been published on the event page.
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Fifth EMA/HMA Big Data Stakeholder Forum: video recording
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A video recording of the fifth annual Big Data multi-stakeholder forum held on 28 November 2024 has been published on the event page.
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Conversations on Cancer - Pediatric Cancers: video recording
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The video recording of the online event Conversations on Cancer - Pediatric Cancers: Navigating the Challenges Together held on 19 November 2024 has been published on the event page.
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Upcoming events
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EMA press briefing on human medicines in 2024
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On 16 January at 14:00-14:45 CET, EMA will hold its first press briefing of 2025 to discuss developments in human medicines in 2024. We will highlight the overarching trends and key advancements, with special considerations for medicines in neurology and psychiatric disorders. The briefing will be broadcast live.
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ACT EU workshop on ICH E6 R3 (principles and Annex 1)
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Registration for this hybrid multistakeholder workshop is no longer possible, but it can be followed through the live broadcast. For more details, please consult the events page.
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19/02/2025 - 20/02/2025
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Open consultations
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Scientific committee and working party activities
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EMA publications
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CHMP Workplan 2025
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The CHMP has published its workplan for 2025 adopted in its meeting on 2 December 2024.
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How EMA involves stakeholders
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From lab to patient: how EMA approves medicines
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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-01-25-010-EN-Q
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