Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2024
14 new medicines recommended for approval; another 11 medicines recommended for extension of therapeutic indications
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EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2024 meeting.
The CHMP recommended granting a marketing authorisation for Anzupgo (delgocitinib), a medicine intended for the treatment of moderate to severe chronic hand eczema in adults for whom topical corticosteroids are inadequate or inappropriate.
The committee recommended granting a conditional marketing authorisation for Iqirvo* (elafibranor), for the treatment of primary biliary cholangitis, a chronic and progressive autoimmune disease that can cause liver damage.
Kayfanda (odevixibat), received a positive opinion under exceptional circumstances for the treatment of cholestatic pruritus in patients with Alagille syndrome, a rare, life-threatening genetic disorder with a wide variety of clinical manifestations affecting the liver, heart, skeleton, eyes, skin, central nervous system, kidneys, and facial features.
The CHMP adopted a positive opinion for Loqtorzi (toripalimab), for the treatment of nasopharyngeal carcinoma and oesophageal squamous cell carcinoma.
Vevizye (ciclosporin), received a positive opinion from the CHMP for the treatment of adult patients with moderate to severe dry eye disease which has not improved despite treatment with tear substitutes.
The CHMP recommended granting a marketing authorisation for Vyloy* (zolbetuximab), to treat gastric or gastro-oesophageal junction adenocarcinoma, a cancer of the stomach.
A positive opinion was adopted for Yuvanci (macitentan / tadalafil), for the treatment of pulmonary arterial hypertension, a chronic and progressive disease of the small pulmonary arteries that is characterised by vascular proliferation and remodelling.
The committee adopted positive opinions for six biosimilar medicines:
- Eksunbi (ustekinumab) and Fymskina (ustekinumab), for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease.
- Ituxredi (rituximab), for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis and pemphigus vulgaris.
- Otulfi (ustekinumab), for the treatment of plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease.
- Ranibizumab Midas (ranibizumab), for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion and visual impairment due to choroidal neovascularisation.
- Tuznue (trastuzumab), for the treatment of breast and gastric cancer.
The committee also recommended granting a marketing authorisation for Axitinib Accord (axitinib), a generic medicine for the treatment of adult patients with advanced renal cell carcinoma.
Negative opinion for one medicine
The CHMP recommended not granting a marketing authorisation for Leqembi (lecanemab), a medicine intended for the treatment of Alzheimer’s disease. The committee considered that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine, in particular the frequent occurrence of amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain of patients who received Leqembi.
For more information on this negative opinion, see the question-and-answer document in the grid below.
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: Arexvy, Braftovi, Edurant, Keytruda, Mektovi, Opsumit, Padcev, Rybrevant, Slenyto, Spevigo and Tecentriq.
Re-examination of recommendations
The marketing authorisation holders for Masitinib AB Science* (masitinib), Syfovre (pegcetacoplan) and Translarna* (ataluren) have requested a re-examination of the opinions adopted during the committee’s June 2024 meeting. Upon receipt of the grounds of the requests, the CHMP will re-examine its opinions and issue final recommendations.
Other updates
The CHMP has recommended strengthening existing advice to minimise the risks from interactions between the weight loss medicine Mysimba (naltrexone / bupropion) and opioid-containing medicines, such as the opioid painkillers morphine and codeine, other opioids used during surgery, and certain medicines for cough, cold or diarrhoea. For more information, see the public health communication in the grid below.
The CHMP has finalised its assessment of an application to extend the use of the weight loss medicine Wegovy (semaglutide) to include prevention of major cardiovascular problems in adults with established cardiovascular disease and a body mass index (BMI) of at least 27 kg/m2. The CHMP considered that this use is already covered by the approved indication for weight management and therefore did not agree to add a separate indication for the prevention of cardiovascular disease. Instead, it recommended to include additional information from a study in the product information. For more information on the CHMP opinion for this medicine, see the question-and-answer document in the grid below.
Agenda and minutes
The agenda of the July 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 July 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
Anzupgo
- International non-proprietary name (INN)
delgocitinib
- Marketing-authorisation applicant
LEO Pharma A/S
- Therapeutic indication
Treatment of moderate to severe chronic hand eczema (CHE)
- More information
Iqirvo
- INN
elafibranor
- Marketing-authorisation applicant
Ipsen Pharma
- Therapeutic indication
Treatment of primary biliary cholangitis (PBC)
- More information
Kayfanda
- INN
odevixibat
- Marketing-authorisation applicant
Ipsen Pharma
- Therapeutic indication
Treatment of cholestatic pruritus in Alagille syndrome (ALGS)
- More information
Loqtorzi
- INN
toripalimab
- Marketing-authorisation applicant
TMC Pharma (EU) Limited
- Therapeutic indication
Combination treatment for metastatic or recurrent locally advanced nasopharyngeal carcinoma and for metastatic or recurrent oesophageal squamous cell carcinoma
- More information
Vevizye
- INN
ciclosporin
- Marketing-authorisation applicant
Novaliq GmbH
- Therapeutic indication
Treatment of dry eye disease in adult patients
- More information
Vyloy
- INN
zolbetuximab
- Marketing-authorisation applicant
Astellas Pharma Europe B.V.
- Therapeutic indication
Treatment of locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma
- More information
Yuvanci
- INN
macitentan / tadalafil
- Marketing-authorisation applicant
Janssen-Cilag International NV
- Therapeutic indication
Treatment of pulmonary arterial hypertension (PAH) in adults
- More information
Positive recommendations on new biosimilar medicines
Eksunbi
- INN
ustekinumab
- Marketing-authorisation applicant
Samsung Bioepis NL B.V.
- Therapeutic indication
Treatment of Crohn’s disease, Ulcerative colitis, Plaque psoriasis, Paediatric plaque psoriasis and Psoriatic arthritis (PsA)
- More information
Fymskina
- INN
ustekinumab
- Marketing-authorisation applicant
Formycon AG
- Therapeutic indication
Treatment of Crohn’s disease, Ulcerative colitis, Plaque psoriasis, Paediatric plaque psoriasis and Psoriatic arthritis (PsA)
- More information
Ituxredi
- INN
rituximab
- Marketing-authorisation applicant
Reddy Holding GmbH
- Therapeutic indication
Treatment of Non-Hodgkin's lymphoma (NHL), Chronic lymphocytic leukaemia (CLL) and Rheumatoid arthritis
- More information
Otulfi
- INN
ustekinumab
- Marketing-authorisation applicant
Fresenius Kabi Deutschland GmbH
- Therapeutic indication
Treatment of Crohn’s disease, Plaque psoriasis, Paediatric plaque psoriasis and Psoriatic arthritis (PsA)
- More information
Ranibizumab Midas
- INN
ranibizumab
- Marketing-authorisation applicant
MIDAS Pharma GmbH
- Therapeutic indication
Treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularisation (CNV)
- More information
Tuznue
- INN
trastuzumab
- Marketing-authorisation applicant
Prestige Biopharma Belgium
- Therapeutic indication
Indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) and HER2 positive early breast cancer (EBC)
- More information
Positive recommendation on new generic medicine
Axitinib Accord
- INN
axitinib
- Marketing-authorisation applicant
Accord Healthcare S.L.U.
- Therapeutic indication
Treatment of adult patients with advanced renal cell carcinoma (RCC)
- More information
Negative recommendation on new medicine
Leqembi
- INN
lecanemab
- Marketing-authorisation applicant
Eisai GmbH
- Therapeutic indication
A disease modifying treatment in adult patients with Mild Cognitive Impairment due to Alzheimer’s disease and Mild Alzheimer’s disease (Early Alzheimer’s disease)
- More information
Positive recommendations on new therapeutic indications
Arexvy
- Common name
Respiratory syncytial virus, glycoprotein F, recombinant, stabilised in the pre-fusion conformation, adjuvanted with AS01E
- Marketing-authorisation holder
GlaxoSmithkline Biologicals S.A.
- More information
Braftovi
- INN
encorafenib
- Marketing-authorisation holder
Pierre Fabre Medicament
- More information
Edurant
- INN
rilpivirine
- Marketing-authorisation holder
Janssen-Cilag International N.V.
- More information
Mektovi
- INN
binimetinib
- Marketing-authorisation holder
Pierre Fabre Medicament
- More information
Keytruda
- INN
pembrolizumab
- Marketing-authorisation holder
Merck Sharp & Dohme B.V.
- More information
Opsumit
- INN
macitentan
- Marketing-authorisation holder
Janssen-Cilag International N.V.
- More information
Padcev
- INN
enfortumab vedotin
- Marketing-authorisation holder
Astellas Pharma Europe B.V.
- More information
Rybrevant
- INN
amivantamab
- Marketing-authorisation holder
Janssen-Cilag International N.V.
- More information
Slenyto
- INN
melatonin
- Marketing-authorisation holder
RAD Neurim Pharmaceuticals EEC SARL
- More information
Spevigo
- INN
spesolimab
- Marketing-authorisation holder
Boehringer Ingelheim International GmbH
- More information
Tecentriq
- INN
atezolizumab
- Marketing-authorisation holder
Roche Registration GmbH
- More information
Re-examination of recommendations
Masitinib AB Science
- INN
masitinib
- Marketing-authorisation applicant
AB Science
- Therapeutic indication
In combination with riluzole for the treatment of adult patients with amyotrophic lateral sclerosis (ALS)
- More information
Syfovre
- INN
pegcetacoplan
- Marketing-authorisation applicant
Apellis Europe B.V.
- Therapeutic indication
Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
- More information
Translarna
- INN
ataluren
- Marketing-authorisation holder
PTC Therapeutics International Limited
- More information