EMA's CHMP Recommended 39 Drugs for Approval in First Half of 2014

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 07-11-2014 19:58


The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended 39 medicines for marketing authorization in the first half of 2014, which was down year-over-year, but higher than 2012 levels. It 2013, the CHMP had recommended 44 medicines in the first half of 2013 and 33 in the first half of 2012.

CHMP is the committee is responsible for preparing opinions for EMA on medicines for human use. The recommendations cover new molecular entities (small molecules and biologics), biosimilars, generics, hybrid medicines, and informed consent applications, and pediatric marketing authorizations. Hybrid medicines are generic medicines that is based on a reference medicine, but has a different strength, different route of administration, or different indication from the reference medicine. An informed consent application requires that reference is made to an authorized medicinal product and that the marketing authorization holder of the reference product has given consent to the use of the dossier in the application procedure.

Of the 39 recommendations from CHMP, 18 for non-orphan medicines, eight for orphan medicines, two for biosimilars, 10 for generics, hybrid, and informed consent applications (six for generic or informed consent applications), and one pediatric marketing authorization. Among the medicines recommended are the anticancer medicines Mekinist (trametinib) and Gazyvaro (obinutuzumab), the anti-inflammatory Entyvio (vedolizumab), the anti-infective Daklinza (daclatasvir), as well as Translarna (ataluren) and Sylvant (siltuximab), which are both intended for the treatment of rare conditions.

In the first half of 2014, eight medicines were recommended for the treatment of rare diseases. This number includes three medicines for which the recommended conditional approval, but whose applications were withdrawn by the sponsor prior to a final decision by the European Commission. The number of medicines recommended for approval via the European Union based on generic or informed consent applications was six, compared to 13 in the first half of 2013.

Source: EMA


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