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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025

Eight new medicines recommended for approval; one positive opinion for a medicine intended for use outside the EU
NewsHumanMedicinesMedicines for use outside the EU

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

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

Withdrawal of initial marketing authorisation application

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

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