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EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its January 2025 meeting.
The CHMP recommended granting a marketing authorisation for Capvaxive (pneumococcal polysaccharide conjugate vaccine (21-valent)), a vaccine intended for the prevention of invasive disease and pneumonia caused by streptococcus pneumoniae bacteria in adults.
The committee adopted a positive opinion for Datroway (datopotamab deruxtecan) for, the treatment of breast cancer.
Tivdak (tisotumab vedotin) received a positive opinion from the CHMP for the treatment of recurrent or metastatic cervical cancer.
The committee recommended granting a marketing authorisation for Vimkunya (chikungunya vaccine (recombinant, adsorbed)), a new vaccine to protect young people from 12 years of age and adults against disease caused by the Chikungunya virus. This medicine was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs. See more details in the news announcement in the grid below.
The CHMP adopted positive opinions for three biosimilar medicines:
A generic medicine, Eltrombopag Accord (eltrombopag), received a positive opinion for the treatment of adults and children with primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C.
The CHMP adopted a positive opinion for Ivermectin/Albendazole (ivermectin/albendazole), for the treatment of infections caused by several types of worm parasites including lymphatic filariasis, a neglected tropical disease.
This medicine was submitted under a programme named EU-Medicines for all (EU-M4All) that enables EMA to contribute to the protection and promotion of public health beyond the EU and support global regulatory capacity building. EMA’s positive scientific opinion will help streamline World Health Organization (WHO) prequalification and facilitate national registration of ivermectin/albendazole for use in public health programs in countries where the targeted diseases are endemic.
See more details in the news announcement in the grid below.
The committee recommended extensions of indication for eight medicines that are already authorised in the EU: Breyanzi, Imfinzi, Opdivo, Ronapreve, Rxulti, Sivextro, Slenyto and Yervoy.
Applications for an initial marketing authorisation for two medicines were withdrawn: Datopotamab deruxtecan Daiichi Sankyo (datopotamab deruxtecan) was intended for the treatment of adults with non-squamous non-small cell lung cancer; Nugalviq* intended for the treatment of classic galactosaemia, a condition where the body cannot break down a sugar called galactose.
Question-and-answer documents on the withdrawals of these two medicines are available in the grid below.
The European Commission has asked the committee to consider information on the safety of Leqembi (lecanemab) that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion. The CHMP will now consider the Commission’s request and provide a response after its plenary meeting in February.
Leqembi received a positive opinion 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 in November.
More information is available on EMA’s website.
The agenda of the January 2025 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
Key figures from the January 2025 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.
pneumococcal polysaccharide conjugate vaccine (21-valent)
Merck Sharp & Dohme B.V.
Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae
datopotamab deruxtecan
Daiichi Sankyo Europe GmbH
Treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least an additional line of chemotherapy in the advanced setting.
tisotumab vedotin
Pfizer Europe MA EEIG
Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy
Chikungunya vaccine (recombinant, adsorbed)
Bavarian Nordic A/S
Prevention of disease caused by chikungunya (CHIKV) virus
pegfilgrastim
CuraTeQ Biologics s.r.o.
Treatment of neutropenia
aflibercept
Amgen Technology (Ireland) Unlimited Company
Treatment of age-related macular degeneration (AMD) and visual impairment
aflibercept
Amgen Technology (Ireland) Unlimited Company
Treatment of age-related macular degeneration (AMD) and visual impairment
eltrombopag
Accord Healthcare S.L.U.
Treatment of primary immune thrombocytopenia (ITP), chronic hepatitis C virus (HCV)
lisocabtagene maraleucel / lisocabtagene maraleucel
Bristol-Myers Squibb Pharma EEIG
durvalumab
AstraZeneca AB
nivolumab
Bristol-Myers Squibb Pharma EEIG
casirivimab / imdevimab
Roche Registration GmbH
brexpiprazole
Otsuka Pharmaceutical Netherlands B.V.
tedizolid phosphate
Merck Sharp & Dohme B.V.
melatonin
RAD Neurim Pharmaceuticals EEC SARL
ipilimumab
Bristol-Myers Squibb Pharma EEIG
ivermectin / albendazole
Laboratorios Liconsa S.A.
Treatment of soil-transmitted helminth infections, treatment of microfilaraemia in patients with lymphatic filariasis
datopotamab
Daiichi Sankyo Europe GmbH
Govorestat
Advanz Pharma Limited