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Eight new medicines recommended for approval
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:
- Dyrupeg (pegfilgrastim), intended to shorten the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and help prevent febrile neutropenia after chemotherapy.
- Pavblu (aflibercept) and its duplicate Skojoy (aflibercept), indicated for the treatment of neovascular age-related macular degeneration and visual impairment related to various conditions.
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.
Positive opinion for a medicine intended for use outside EU
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.
Recommendations on extensions of therapeutic indication for eight medicines
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.
Withdrawal of applications
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.
Other updates
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.
Agenda and minutes
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.
CHMP statistics
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.
![CHMP graph January 2025](/sites/default/files/styles/oe_bootstrap_theme_medium_no_crop/public/2025-01/2025_01_CHMP_highlights.png?itok=W3i18Rnm)
Positive recommendations on new medicines
Capvaxive
- Common name
pneumococcal polysaccharide conjugate vaccine (21-valent)
- Marketing authorisation applicant
Merck Sharp & Dohme B.V.
- Therapeutic indication
Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae
- More information
Datroway
- INN
datopotamab deruxtecan
- Marketing authorisation applicant
Daiichi Sankyo Europe GmbH
- Therapeutic indication
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.
- More information
Tivdak
- INN
tisotumab vedotin
- Marketing authorisation applicant
Pfizer Europe MA EEIG
- Therapeutic indication
Treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy
- More information
Vimkunya
- INN
Chikungunya vaccine (recombinant, adsorbed)
- Marketing authorisation applicant
Bavarian Nordic A/S
- Therapeutic indication
Prevention of disease caused by chikungunya (CHIKV) virus
- More information
- News
Positive recommendations on new biosimilar medicines
Dyrupeg
- INN
pegfilgrastim
- Marketing authorisation applicant
CuraTeQ Biologics s.r.o.
- Therapeutic indication
Treatment of neutropenia
- More information
Pavblu
- INN
aflibercept
- Marketing authorisation applicant
Amgen Technology (Ireland) Unlimited Company
- Therapeutic indication
Treatment of age-related macular degeneration (AMD) and visual impairment
- More information
Skojoy
- INN
aflibercept
- Marketing authorisation applicant
Amgen Technology (Ireland) Unlimited Company
- Therapeutic indication
Treatment of age-related macular degeneration (AMD) and visual impairment
- More information
Positive recommendation on new generic medicine
Eltrombopag Accord
- INN
eltrombopag
- Marketing authorisation holder
Accord Healthcare S.L.U.
- Therapeutic indication
Treatment of primary immune thrombocytopenia (ITP), chronic hepatitis C virus (HCV)
- More information
Positive recommendations on new therapeutic indications
Breyanzi
- INN
lisocabtagene maraleucel / lisocabtagene maraleucel
- Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
- More information
Imfinzi
- INN
durvalumab
- Marketing authorisation holder
AstraZeneca AB
- More information
Opdivo
- INN
nivolumab
- Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
- More information
Ronapreve
- INN
casirivimab / imdevimab
- Marketing authorisation holder
Roche Registration GmbH
- More information
Rxulti
- INN
brexpiprazole
- Marketing authorisation holder
Otsuka Pharmaceutical Netherlands B.V.
- More information
Sivextro
- INN
tedizolid phosphate
- Marketing authorisation holder
Merck Sharp & Dohme B.V.
- More information
Slenyto
- INN
melatonin
- Marketing authorisation holder
RAD Neurim Pharmaceuticals EEC SARL
- More information
Yervoy
- INN
ipilimumab
- Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG
- More information
Positive opinions for medicines intended for use outside the EU
Ivermectin / Albendazole
- INN
ivermectin / albendazole
- Marketing authorisation applicant
Laboratorios Liconsa S.A.
- Therapeutic indication
Treatment of soil-transmitted helminth infections, treatment of microfilaraemia in patients with lymphatic filariasis
- More information
- News
Datopotamab deruxtecan Daiichi Sankyo
- INN
datopotamab
- Marketing authorisation applicant
Daiichi Sankyo Europe GmbH
- More information
Nugalviq
- INN
Govorestat
- Marketing authorisation applicant
Advanz Pharma Limited
- More information