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    Home > Active Ingredient News > Drugs Articles > List of new drugs recommended for marketing by the EU CHMP in 2022

    List of new drugs recommended for marketing by the EU CHMP in 2022

    • Last Update: 2023-02-03
    • Source: Internet
    • Author: User
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    On December 16, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) concluded its last working meeting of the year, which issued review opinions on the EU marketing applications of six new drugs
    .
    So far, CHMP has completed the review of 92 new drug marketing applications throughout the year, and has given positive opinions on 89 new drugs (appendix at the end of the article).

    Overall, the total number of new drugs recommended for marketing by CHMP in 2022 decreased compared with 2021, but the number of the world's first batch of new drugs still increased
    steadily.

    The status of the world's first new drugs

    The status of the world's first new drugs

    Among the new drugs recommended by CHMP this year, there are 8 new drugs in the world, of which 7 are biotechnology drugs, including 2 gene therapy drugs, 1 cell therapy drug, 3 antibody drugs and 1 protein drug, and chemical small molecule drugs occupy another seat (Table 1).

    Table 1: CHMP recommended for the first batch of new drugs in the world in 2022

    Gene therapy and cell therapy drugs have been included in the management of advanced therapeutic medical products (ATMP) in the EU, and in 2021, the EU updated and improved the guidelines for the development of gene and cell therapy drugs to actively guide and support the development of
    ATMP.
    This year, CHMP recommended the approval of 3 gene therapy drugs and 3 cell therapy drugs, of which 2 gene therapy drugs and 1 cell therapy drug are among the first new drugs
    in the world 。 They are: PTC Intra-brain injection gene therapy Upstaza (eladocagene) developed by Therapeutics to treat the rare disease aromatic L-amino acid decarboxylase (AADC) deficiency exuparvovec), the severe hemophilia A gene therapy Roctavian (valoctocogene) developed by BioMarin Pharmaceutical roxaparvovec) and Atara Biotherapeutics and Pierre Fabre collaborated to develop the allogeneic T cell therapy Ebvallo (tabelecleucel).

    It is worth mentioning that unlike the highly customized autologous CAR-T therapy on the market, Ebvallo uses EBV from donors T cells, which can be quickly delivered to patients within three days, will be a milestone in the commercialization of universal cell therapies
    .

    Bispecific antibodies are regarded as the second generation of antibody therapy for tumor treatment, and it seems to have ushered in an "outbreak" period
    in 2022.
    Among the antibody drugs recommended by CHMP this year, there are 3 bispecific antibody drugs, two of which are the world's first first-in-class products, CD20 developed by Roche x CD3 targets the bispecific antibody Lunsumio (mosunetuzumab) and the first fully humanized BCMA x CD3 developed by Johnson & Johnson Targeting the bispecific antibody Tecvayli (teclistamab).

    The above two drugs are a boon
    for patients with different types of multiple recurrent or refractory hematological tumors.

    The status of the first new drugs in the EU

    The status of the first new drugs in the EU

    Generic medicine, biosimilar medicine, and hybrid drugs are excluded medicine), CHMP recommended a total of 51 new drugs this year, covering 14 therapeutic areas
    .
    Among them, anti-tumor drugs still rank first, accounting for about 1/3 of the total, and the indications include hematologic tumors, prostate cancer, lung cancer, liver cancer, eye tumors, urothelial cancer, etc
    .
    Anti-infective drugs ranked second, with 9 new drugs recommended, including 4 vaccines
    .
    Gastrointestinal system medication ranked third, with 5 drugs recommended
    .
    Together, these TOP3 therapeutic areas account for nearly 60% (Figure 1).

    Figure 1: Distribution of CHMP recommended new drug therapeutic areas in FY2022

    In terms of R&D companies, AstraZeneca AB and Novartis are undoubtedly the big winners this year, with 4 new drugs recommended respectively, tied for first
    .
    In addition, including Roche, Eli Lilly、Janssen-Cilag、Takeda、Genzyme Europe BV、 Bristol-Myers Seven companies, including giants such as Squibb, each had 2 new drugs recommended, tied for second
    .
    The other 29 companies contributed a new drug
    to the EU market.

    Attached: 2022 EU CHMP recommended new drugs for marketing

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