CHMP Recommends Nine Drugs for Approval, Including Six Orphans

July 2, 2018

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval or marketing authorization at its June meeting, including the EU’s first two CAR-T cell therapies.

The committee suggested that two orphan drugs, Novartis’ Kymriah (tisagenlecleucel) and Kite Pharma’s Yescarta (axicabtagene ciloleucel) — both CAR-T cell therapies for treating  blood cancers — receive marketing authorizations.  They are the first medicines supported by the EMA’s Priority Medicines (PRIME) scheme to receive positive CHMP opinions.

The other orphan drugs recommended for approval include: Ablynx’s Cablivi (caplacizumab), for treating acquired thrombotic thrombocytopenic purpora; Ultragenyx’s Mepsevii (vestronidase alfa) for the treatment of mucopolysacharidosis type VII; Baxalta’s Veyvondi (vonicog alfa) for treating von Willebrand disease; and Jazz’s Vyxeos (daunorubicin/cytarabine) for the treatment of acute myeloid leukemia.

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