Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023

EMA’s human medicines committee (CHMP) recommended nine new medicines for Approval at its March 2023 meeting, of particular interest the following:

• the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and older who have previously been vaccinated with a mRNA COVID-19 vaccine. It is the eighth vaccine recommended in the European Union (EU) for protecting against COVID-19 and, together with the vaccines already authorised, will support vaccination campaigns in EU Member States during the pandemic. An overview of all the COVID-19 vaccines authorised in the EU is available on EMA’s website. See more information.

The committee adopted positive opinions for recommendations on Extensions of therapeutic indication for six medicines, of particular interest the following:

• Breyanzi (=> Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy)  

Withdrawals of applications

Three applications for marketing authorisation were withdrawn, of particular interest the following: 

• Onteeo, intended for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, and COVID-19. Onteeo is a duplicate of a medicine which is currently under evaluation.
• Raltegravir Viatris, intended for the treatment of human immunodeficiency virus (HIV-1) infection. See more information