Seven new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2023 meeting.
The CHMP adopted a positive opinion for Agamree* (vamorolone), for the treatment of Duchenne muscular dystrophy, a genetic disorder characterised by the progressive loss of muscle function.
The committee recommended granting a conditional marketing authorisation 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. 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…
