Six new drugs recommended for approval by EMA/CHMP, including two biosimilars

28 January 2017

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its January meeting.

The Committee recommended granting a marketing authorization for US pharma giant Pfizer’s (NYSE: PFE) Xeljanz (tofacitinib) for the treatment of rheumatoid arthritis.

One hybrid medicine, Jylamvo (methotrexate) – from UK-based Therakind, received a positive opinion for the treatment of rheumatological disorders and psoriasis, and for the maintenance treatment of acute lymphoblastic leukemia (ALL). Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.

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