Following its October meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends granting marketing authorizations for the following new products:

• Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy, a genetic disorder characterized by progressive muscle function decline. Company: Santhera.

• The Committee recommended granting a conditional marketing authorization for Elrexfio (elranatamab) for the treatment of adult patients with relapsed or refractory multiple myeloma, a rare cancer of the bone marrow that affects plasma cells, a type of white blood cell that produces antibodies. Company: Pfizer. The drug was supported through the EMA’s Priority Medicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with the potential to address unmet medical needs.

• Elucirem (gadopiclenol) and its duplicate Vueway, two diagnostic medicines to improve the detection, visualization and characterization of lesions in the central nervous system and other body areas, including the breast, liver and prostate. Company: Guerbet.

• Loargys (pegzilarginase) received a positive opinion under exceptional circumstances for the treatment of hyperargininemia, a rare disease with neurological clinical symptoms including spasticity, ataxia, hyperreflexia, incoordination and seizures. Company: Immedica Pharma.

• Rezzayo (rezafungin) for the treatment of invasive candidiasis, a serious fungal infection caused by Candida. Company: Cidara Therapeutics.

• Veoza (fezolinetant) for the treatment of moderate to severe vasomotor symptoms (hot flushes) associated with menopause. Company: Astellas Pharma.

Extended indications

Eight agents are recommended for extended use: Brukinsa, Imfinzi, Jemperli, Keytruda, Praluent, Prevymis*, Rubraca and Veyvondi.

(Translated using DeepL with additional editing by Kristoffer Grønbæk)