Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2024
8 new medicines recommended for approval; another 12 medicines recommended for extension of their therapeutic indications
NewsHumanMedicines
EMA’s human medicines committee elects new Chair
The Committee for Human Medicinal Products (CHMP) elected Bruno Sepodes as its new chair. Professor Sepodes starts his three-year mandate on 21 September and succeeds Dr Harald Enzmann as chair, who completed the maximum two three-year terms allowed for CHMP chairs.
More information is available in EMA’s news announcement.
Eight new medicines recommended for approval
The CHMP recommended granting a marketing authorisation for Elahere* (mirvetuximab soravtansine), a medicine intended for the treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
The committee recommended granting a marketing authorisation for Hetronifly* (serplulimab), for the treatment of extensive-stage small cell lung cancer.
Hympavzi* (marstacimab), received a positive opinion for the treatment of bleeding episodes in patients aged 12 years and older with severe haemophilia A or B, two types of a rare inherited bleeding disorder.
The CHMP adopted a positive opinion for Penbraya (meningococcal groups A, C, W, Y conjugate and group B vaccine (recombinant, adsorbed)), a vaccine indicated for immunisation against invasive disease caused by Neisseria meningitidis, a Gram-negative bacterium, often referred to as meningococcus, that colonizes the upper respiratory tract, which, in some individuals, can cause serious, life-threatening invasive meningococcal disease.
Theralugand (lutetium (177lu) chloride), a radiopharmaceutical precursor, received a positive opinion from the CHMP. Theralugand must be used only for the radiolabelling of carrier medicines that have been specifically developed and authorised for radiolabelling with lutetium chloride.
The committee adopted positive opinions for Afqlir (aflibercept) and Opuviz (aflibercept), two biosimilar medicines intended for the treatment of age-related macular degeneration, a progressive retinal macular disease causing gradual vision impairment mainly in elderly people.
The committee also recommended granting a marketing authorisation for Pomalidomide Teva (pomalidomide), a generic medicine for the treatment of multiple myeloma, a rare cancer of the bone marrow that affects plasma cells, a type of white blood cell that produces antibodies.
Recommendations on extensions of therapeutic indication for 12 medicines
The CHMP has recommended extending the indication of the smallpox and mpox vaccine Imvanex to adolescents from 12 to 17 years of age. This assessment has important implications for the global response to the mpox outbreak in the Democratic Republic of the Congo and other countries, that was declared a public health emergency of international concern by the World Health Organization on 14 August 2024. See more details in the news announcement in the grid below.
The committee recommended additional extensions of indication for 11 medicines that are already authorised in the EU: Aflunov, Buccolam, Darzalex*, Dupixent, Esperoct, Fasenra, Keytruda, Otezla, Pravafenix, Synjardy and Zavicefta.
Start of re-examination of recommendations
The applicant for Leqembi (lecanemab) has requested a re-examination of the opinion adopted during the committee’s July 2024 meeting. Upon receipt of the grounds of the request, the CHMP will re-examine its opinion and issue a final recommendation.2
Outcome of re-examination
Following a re-examination, the CHMP confirmed its initial recommendation to refuse the granting of a marketing authorisation for Syfovre (pegcetacoplan). This medicine was intended for the treatment of geographic atrophy secondary to age-related macular degeneration.
Withdrawal of applications
One application for marketing authorisation was withdrawn. Durysta (bimatoprost implant) was intended for the reduction of intraocular pressure in adults with open angle glaucoma or ocular hypertension.
The applications to extend the therapeutic indications of Tecentriq, a medicine to treat different types of cancers, and Sialanar, a medicine for treating severe drooling of saliva in children and adolescents with conditions affecting the nervous system, were withdrawn.
Question-and-answer documents on the withdrawals of these medicines are available in the grid below.
Other updates
The CHMP gave positive opinions to update the composition of the mRNA vaccine Spikevax1, to target the SARS-CoV-2 JN.1 variant of the virus that causes COVID-19, and Comirnaty for the KP.2 subvariant. The revision of these vaccines is in line with the recommendations issued by EMA’s Emergency Task Force to update COVID-19 vaccines to target the SARS-CoV-2 variants for the 2024/2025 vaccination campaign.
Agenda and minutes
The agenda of the September 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 September 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.
1CHMP opinion adopted on 9 September 2024
2This news announcement was updated on 23 September 2024 to include the start of re-examination of Leqembi (lecanemab)
Positive recommendations on new medicines
Elahere
- International non-proprietary name (INN)
mirvetuximab soravtansine
- Marketing-authorisation applicant
AbbVie Deutschland GmbH & Co. KG
- Therapeutic indication
Treatment of ovarian, fallopian tube, or primary peritoneal cancer
- More information
Hetronifly
- INN
serplulimab
- Marketing-authorisation applicant
Henlius Europe GmbH
- Therapeutic indication
First-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
- More information
Hympavzi
- INN
marstacimab
- Marketing-authorisation applicant
Pfizer Europe Ma EEIG
- Therapeutic indication
Routine prophylaxis of bleeding episodes in patients with haemophilia A or haemophilia B
- More information
Theralugand
- INN
lutetium (177Lu) chloride
- Marketing-authorisation applicant
Eckert & Ziegler Radiopharma GmbH
- Therapeutic indication
Radiolabelling of carrier molecules
,which have been specifically developed for radiolabelling with this radionuclide- More information
Penbraya
- INN
Meningococcal group A, B, C, W and Y vaccine
- Marketing-authorisaton applicant
Pfizer Europe MA EEIG
- Therapeutic indication
Active immunisation to prevent invasive disease caused by Neisseria meningitidis groups A, B, C, W, and Y
- More information
Positive recommendations on new biosimilar medicines
Afqlir
- INN
aflibercept
- Marketing-authorisation applicant
Sandoz GmbH
- Therapeutic indication
Treatment of age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO), due to diabetic macular oedema (DME) and due to myopic choroidal neovascularisation (myopic CNV) or central RVO)
- More information
Opuviz
- INN
aflibercept
- Marketing-authorisation applicant
Samsung Bioepis NL B.V.
- Therapeutic indication
Treatment of age-related macular degeneration (AMD) and visual impairment
- More information
Positive recommendation on new generic medicine
Pomalidomide Teva
- INN
pomalidomide
- Marketing-authorisation applicant
Teva GmbH
- Therapeutic indication
In combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma (MM)
- More information
Positive recommendations on extensions of therapeutic indications
Aflunov
- INN
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
- Marketing-authorisation holder
Seqirus S.r.l.
- More information
Buccolam
- INN
midazolam
- Marketing-authorisation holder
Neuraxpharm Pharmaceuticals S.L.
- More information
Darzalex
- INN
daratumumab
- Marketing-authorisation holder
Janssen-Cilag International N.V.
- More information
Dupixent
- INN
dupilumab
- Marketing-authorisation holder
Sanofi Winthrop Industrie
- More information
Esperoct
- INN
turoctocog alfa pegol
- Marketing-authorisation holder
Novo Nordisk A/S
- More information
Fasenra
- INN
benralizumab
- Marketing-authorisation holder
AstraZeneca AB
- More information
Imvanex
- INN
smallpox and monkeypox vaccine (live modified vaccinia virus Ankara)
- Marketing-authorisation holder
Bavarian Nordic A/S
- More information
Keytruda
- INN
pembrolizumab
- Marketing-authorisation holder
Merck Sharp & Dohme B.V.
- More information
Otezla
- INN
apremilast
- Marketing-authorisation holder
Amgen Europe B.V.
- More information
Pravafenix
- INN
fenofibrate / pravastatin sodium
- Marketing-authorisation holder
Laboratoires SMB s.a.
- More information
Synjardy
- INN
empagliflozin / metformin
- Marketing-authorisation holder
Boehringer Ingelheim International GmbH
- More information
Zavicefta
- INN
ceftazidime / avibactam
- Marketing-authorisation holder
Pfizer Ireland Pharmaceuticals
- More information
Outcome of re-examination of initial application procedures
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
Withdrawal of initial application
Durysta
- INN
bimatoprost implant
- Marketing-authorisation applicant
Abbvie Deutschland GmbH & Co. KG
- More information
Withdrawal of extension of indication
Tecentriq
- INN
atezolizumab
- Marketing-authorisation holder
Roche Registration GmbH
- More information
Sialanar
- INN
glycopyrronium bromide
- Marketing-authorisation holder
Proveca Pharma Limited
- More information