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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.
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.
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.
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
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.
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.
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.
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.
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)
mirvetuximab soravtansine
AbbVie Deutschland GmbH & Co. KG
Treatment of ovarian, fallopian tube, or primary peritoneal cancer
serplulimab
Henlius Europe GmbH
First-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
marstacimab
Pfizer Europe Ma EEIG
Routine prophylaxis of bleeding episodes in patients with haemophilia A or haemophilia B
lutetium (177Lu) chloride
Eckert & Ziegler Radiopharma GmbH
Radiolabelling of carrier molecules, which have been specifically developed for radiolabelling with this radionuclide
Meningococcal group A, B, C, W and Y vaccine
Pfizer Europe MA EEIG
Active immunisation to prevent invasive disease caused by Neisseria meningitidis groups A, B, C, W, and Y
aflibercept
Sandoz GmbH
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)
aflibercept
Samsung Bioepis NL B.V.
Treatment of age-related macular degeneration (AMD) and visual impairment
pomalidomide
Teva GmbH
In combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma (MM)
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Seqirus S.r.l.
midazolam
Neuraxpharm Pharmaceuticals S.L.
daratumumab
Janssen-Cilag International N.V.
dupilumab
Sanofi Winthrop Industrie
turoctocog alfa pegol
Novo Nordisk A/S
benralizumab
AstraZeneca AB
smallpox and monkeypox vaccine (live modified vaccinia virus Ankara)
Bavarian Nordic A/S
pembrolizumab
Merck Sharp & Dohme B.V.
apremilast
Amgen Europe B.V.
fenofibrate / pravastatin sodium
Laboratoires SMB s.a.
empagliflozin / metformin
Boehringer Ingelheim International GmbH
ceftazidime / avibactam
Pfizer Ireland Pharmaceuticals
pegcetacoplan
Apellis Europe B.V.
Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
bimatoprost implant
Abbvie Deutschland GmbH & Co. KG
atezolizumab
Roche Registration GmbH
glycopyrronium bromide
Proveca Pharma Limited