EU gives green light for 7 new medicines

The European Medicines Agency (EMA) has recommended seven medicines for approval at its October 2023 meeting. The brings the total number of newly approved medicines this year to 62.

The Agency’s committee on human medicines (CHMP) approved the following:

• Agamree(vamorolone), for the treatment of Duchenne muscular dystrophy, a genetic disorder characterised by the progressive loss of muscle function.
• Elrexfio(elranatamab), conditionally authorised 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. 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.
• Elucirem(gadopiclenol) and its duplicate Vueway, two diagnostic medicines to improve detection, visualisation and assist in the characterisation of lesions in the central nervous system and in other body regions, including the breast, the liver and the prostate.
• Loargys(pegzilarginase), for the treatment of hyperargininemia, a rare disease with neurological clinical signs including spasticity, ataxia, hyperreflexia, incoordination, and seizures.
• Rezzayo(rezafungin), for the treatment of invasive candidiasis, a serious fungal infection caused by Candida.
• Veoza(fezolinetant), for the treatment of moderate-to-severe vasomotor symptoms (hot flushes) associated with menopause.

The committee also recommended eight extensions of indication for medicines that are already authorised in the European Union.

These are Brukinsa, Imfinzi, Jemperli, Keytruda, Praluent, Prevymis, Rubraca, and Veyvondi.