Latest batch of novel meds recommended for approval by CHMP
The European Medicines Agency’s human medicines committee (CHMP) recommended 10 novel medicines for approval at its July 2022 meeting. The opinions will go to the European Commission for final endorsement, which usually take two to three months.
The CHMP recommended granting a marketing authorization for Alnylam’s (Nasdaq: ALNY) Amvuttra (vutrisiran) for the treatment of adults with hereditary transthyretin-mediated amyloidosis, a rare life-threatening disease that damages multiple nerves across the body.
The committee adopted a positive opinion for Celdoxome (doxorubicin hydrochloride), from YES Pharmaceuticals, for the treatment of breast cancer, ovarian cancer, multiple myeloma and Kaposi's sarcoma, a type of cancer that affects people with AIDS.
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