CHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
EMA’s human medicines committee (CHMP) recommended eight medicines for EU marketing authorisation at its January 2025 meeting.
Other positive opinion highlights include recommendation of oncology-indicated medicines Datroway (datopotamab deruxtecan) for breast cancer and Tivdak (tisotumab vedotin) for recurrent or metastatic cervical cancer.
CHMP’s positive opinions for vaccines
In addition, the human medicines committee recommended the vaccine Capvaxive (pneumococcal polysaccharide conjugate vaccine (21-valent)), as a preventative treatment for invasive disease and pneumonia caused by streptococcus pneumoniae bacteria in adults.
New vaccine Vimkunya (chikungunya vaccine (recombinant, adsorbed)) was also recommended for individuals 12 years old and adults to prevent disease caused by the Chikungunya virus.
Biosimilars given a positive opinion
• Dyrupeg (pegfilgrastim) to reduce the duration of neutropenia and help prevent febrile neutropenia following chemotherapy.
• Pavblu (aflibercept) and Skojoy (aflibercept) for the treatment of neovascular age-related macular degeneration and visual impairment related to various conditions.
Additionally, the CHMP recommended the generic medicine Eltrombopag Accord (eltrombopag) to treat primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C.
Further developments
The EMA’s committee also gave positive opinions to extend the indications for the following eight medicines: Breyanzi, Imfinzi, Opdivo, Ronapreve, Rxulti, Sivextro, Slenyto and Yervoy.
Furthermore, the CHMP withdrew initial marketing authorisation applications for two medicines: Datopotamab deruxtecan Daiichi Sankyo (datopotamab deruxtecan), to treat adults with non-squamous non-small cell lung cancer; Nugalviq to treat classic galactosaemia.
Lastly, the European Commission (EC) requested safety information of Leqembi (lecanemab) that was made available following the CHMP’s opinion on the drug last year. The drug was indicated as a treatment for certain patients with mild cognitive impairment or dementia due to Alzheimer’s disease. The EC questioned whether this would necessitate an update of the CHMP’s opinion made in November 2024.
Related topics
Anti-Cancer Therapeutics, Big Pharma, Biologics, Biopharmaceuticals, Clinical Development, Clinical Trials, Data Analysis, Drug Development, Drug Markets, Drug Safety, Industry Insight, Regulation & Legislation, Research & Development (R&D), Technology, Therapeutics, Vaccine Technology, Vaccines
Related drugs
adsorbed)), Aflibercept, Biosimilars, Breyanzi, Capvaxive (pneumococcal polysaccharide conjugate vaccine (21-valent)), Datopotamab deruxtecan (Dato-DXd), Datroway (datopotamab deruxtecan), Dyrupeg (pegfilgrastim), Eltrombopag Accord (eltrombopag), Generics, Imfinzi, Leqembi (lecanemab-irmb), Nugalviq, Opdivo, Pavblu (aflibercept), Ronapreve, Rxulti, Sivextro, Skojoy (aflibercept), Slenyto, Tivdak (tisotumab vedotin), Vimkunya (chikungunya vaccine (recombinant, Yervoy
Related diseases & conditions
Alzheimer's, Breast cancer, Cervical cancer, Chikungunya virus, Dementia, galactosaemia, hepatitis C, neovascular age-related macular degeneration, neutropenia, non-small cell lung cancer (NSCLC), Pneumonia, thrombocytopenia
