Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024
Leqembi (lecanemab) recommended for treatment of early Alzheimer’s disease
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Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2024 meeting.
The committee recommended granting a conditional marketing authorisation for Augtyro (repotrectinib), a medicine intended for the treatment of adults and adolescents with advanced solid tumours, and adults with locally advanced or metastatic non-small cell lung cancer.
The CHMP recommended granting a marketing authorisation under exceptional circumstances for Gohibic (vilobelimab), for the treatment of adult patients with SARS‑CoV2‑induced acute respiratory distress syndrome who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation with or without extracorporeal membrane oxygenation. EMA’s Emergency Task force was consulted during the assessment of this medicine.
Lazcluze (lazertinib) received a positive opinion for the first-line treatment of adult patients with advanced non-small cell lung cancer in combination with amivantamab.
The committee adopted positive opinions for four biosimilar medicines:
- Baiama (aflibercept) and its duplicate Ahzantive, for the treatment of neovascular age-related macular degeneration, and visual impairment due to macular oedema secondary to retinal vein occlusion, diabetic macular oedema or myopic choroidal neovascularisation.
- Obodence (denosumab), for the treatment of osteoporosis and bone loss.
- Xbryk (denosumab), for the prevention of skeletal-related events in adults with advanced malignancies involving bone, and the treatment of giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Recommendations on extensions of therapeutic indication for 11 medicines
The committee recommended extensions of indication for 11 medicines that are already authorised in the EU: CellCept, Evkeeza, Jakavi, Kevzara, Keytruda, Opdivo, Palforzia, Rybrevant, Sarclisa, Tagrisso and Yervoy.
Negative opinions for two medicines
The CHMP recommended the refusal of marketing authorisations for Cinainu (allium/citrus/paullinia/
cacao), a medicine intended for the treatment of moderate-to-severe alopecia areata, a disease causing hair loss of the scalp or other parts of the body, and Kizfizo* (temozolomide), for the treatment of neuroblastoma, a rare cancer that forms from immature nerve cells.
For more information on these negative opinions, see the question-and-answer documents in the grid below.
Outcomes of re-examination
Following a re-examination, the CHMP has recommended granting a marketing authorisation for Leqembi (lecanemab), for the treatment of mild cognitive impairment (memory and thinking problems) or mild dementia due to Alzheimer’s disease (early Alzheimer’s disease) in patients who have only one or no copy of ApoE4, a certain form of the gene for the protein apolipoprotein E. During the re-examination, the company that applied for authorisation provided additional analyses of the data to support the proposed use in a subgroup of patients. The committee concluded that in the restricted population of patients who have only one or no copy of ApoE4, the benefits of Leqembi outweigh the risks. For more information, see the public health communication in the grid below.
After re-examining its initial opinion, the CHMP recommended updating the advice aimed at minimising the risks of interaction between the weight loss medicine Mysimba (naltrexone/bupropion) and opioid-containing medicines, including painkillers such as morphine and codeine, other opioids used during surgery, and certain medicines for cough, cold or diarrhoea. Opioid medicines may not work effectively in patients taking Mysimba, because one of the active substances in Mysimba, naltrexone, blocks the effects of opioids. There is also a risk of rare but serious and potentially life-threatening reactions, such as seizures and serotonin syndrome (a potentially life-threatening condition that results from having too much serotonin in the body), in people taking Mysimba together with medicines for treating depression and opioids. For more information, see the public health communication in the grid below.
Withdrawal of applications
An application for an initial marketing authorisation was withdrawn. Izelvay (avacincaptad pegol) was intended for the treatment of geographic atrophy caused by age-related macular degeneration, a disease that affects the central part of the retina at the back of the eye.
An application to extend the therapeutic indication of Inaqovi (cedazuridine/decitabine) was also withdrawn. It concerned the use in the treatment of acute myeloid leukaemia, to include myelodysplastic syndromes, conditions where the bone marrow does not make enough healthy blood cells or platelets, and chronic myelomonocytic leukaemia, another type of cancer of the white blood cells.
Question-and-answer documents on the withdrawals of these medicines are available in the grid below.
Agenda and minutes
The agenda of the November 2024 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
CHMP statistics
Key figures from the November 2024 CHMP meeting are represented in the graphic below.
*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
Positive recommendations on new medicines
Augtyro
- International non-proprietary name (INN)
repotrectinib
- Marketing authorisation applicant
Bristol-Myers Squibb Pharma EEIG
- Therapeutic indication
Treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and for solid tumours
- More information
Gohibic
- INN
vilobelimab
- Marketing authorisation applicant
InflaRx GmbH
- Therapeutic indication
Treatment of adult patients with SARS‑CoV2‑induced acute respiratory distress syndrome who are receiving systemic corticosteroids as part of standard of care and receiving invasive mechanical ventilation with or without extracorporeal membrane oxygenation
- More information
Lazcluze
- INN
lazertinib
- Marketing authorisation applicant
Janssen Cilag International
- Therapeutic indication
Treatment of adult patients with advanced non-small cell lung cancer (NSCLC)
- More information
Positive recommendations on new biosimilar medicines
Ahzantive
- INN
aflibercept
- Marketing authorisation applicant
Klinge Biopharma GmbH
- Therapeutic indication
Treatment of age-related macular degeneration (AMD) and visual impairment
- More information
Baiama
- INN
aflibercept
- Marketing authorisation applicant
Formycon AG
- Therapeutic indication
Treatment of age-related macular degeneration (AMD) and visual impairment
- More information
Obodence
- INN
denosumab
- Marketing authorisation applicant
Samsung Bioepis NL B.V.
- Therapeutic indication
Treatment of osteoporosis and bone loss
- More information
Xbryk
- INN
denosumab
- Marketing authorisation applicant
Samsung Bioepis NL B.V.
- Therapeutic indication
Prevention of skeletal related events with advanced malignancies and treatment of giant cell tumour of bone
- More information
Positive recommendations on extensions of therapeutic indications
CellCept
- INN
mycophenolate mofetil
- Marketing authorisation holder
Roche Registration GmbH
- More information
Evkeeza
- INN
evinacumab
- Marketing authorisation holder
Ultragenyx Germany GmbH
- More information
Jakavi
- INN
ruxolitinib
- Marketing authorisation holder
Novartis Europharm Limited
- More information
Kevzara
- INN
sarilumab
- Marketing authorisation holder
Sanofi Winthrop Industrie
- More information
Keytruda
- INN
pembrolizumab
- Marketing authorisation holder
Merck Sharp & Dohme B.V.
- More information
Opdivo
- INN
nivolumab
- Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
- More information
Palforzia
- INN
defatted powder of Arachis hypogaea L., semen (peanuts)
- Marketing authorisation holder
Stallergenes
- More information
Rybrevant
- INN
amivantamab
- Marketing authorisation holder
Janssen-Cilag International N.V.
- More information
Sarclisa
- INN
isatuximab
- Marketing authorisation holder
Sanofi Winthrop Industrie
- More information
Tagrisso
- INN
osimertinib
- Marketing authorisation holder
AstraZeneca AB
- More information
Yervoy
- INN
ipilimumab
- Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
- More information
Negative recommendations on new medicines
Cinainu
- INN
liquid ethanolic extract 30 per cent (W/W) of allium cepa fresh bulb and citrus limon fresh fruit / dry aqueous extract of paullinia cupana seed / dry hydroethanolic extract of theobroma cacao seed
- Marketing authorisation applicant
Legacy Healthcare (France) S.A.S.
- Therapeutic indication
Treatment of alopecia areata in children and adolescents
- More information
Kizfizo
- INN
temozolomide
- Marketing authorisation applicant
Orphelia Pharma
- Therapeutic indication
Treatment of neuroblastoma
- More information
Izelvay
- INN
avacincaptad pegol
- Marketing authorisation applicant
Astellas Pharma Europe B.V.
- More information
Inaqovi
- INN
decitabine / cedazuridine
- Marketing authorisation applicant
Otsuka Pharmaceutical Netherlands B.V.
- More information
Inaqovi: withdrawn application (II-0002)
Outcome of re-examinations
Leqembi
- INN
lecanemab
- Marketing authorisation applicant
Eisai GmbH
- More information
Mysimba
- INN
naltrexone hydrochloride / bupropion hydrochloride
- Marketing authorisation holder
Orexigen Therapeutics Ireland Limited
- More information