European CHMP Opinions And MAA Updates
Executive Summary
This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency's key scientific panel, the Committee for Medicinal Products for Human Use (CHMP), meets once a month and among other things adopts positive or negative opinions on marketing authorization applications (MAAs) filed through the centralized procedure for new molecular entities (NMEs), biosimilars and generic medicines. CHMP opinions are sent to the European Commission, which makes a final, legally binding decision, usually within 67 days.
The CHMP at its monthly plenary meetings also assesses requests for modifications or extensions to existing marketing authorizations.
The table below provides an overview of decisions on new marketing applications, applications to extend the indication of existing marketing authorizations and requests for the re-examination of negative opinions the CHMP has adopted. It also covers the withdrawal of MAAs by companies.
The table has now been updated with 19 products that the CHMP discussed at its latest meeting in January. These products are Ajovy (fremanezumab), Vizimpro (dacomitinib), Idacio (adalimumab), Kromeya (adalimumab), Atazanavir Krka (atazanavir), Febuxostat Krka (febuxostat), Doxolipad (doxorubicin), Edistride (dapagliflozin), Forxiga (dapagliflozin), Hemlibra (emicizumab), Keytruda (pembrolizumab), Mabthera (rituximab), Maviret (glecaprevir/pibrentasvir), Orencia (abatacept), Praluent (alicocumab), Tecentriq (atezolizumab), Cavoley (pegfilgrastim), Efgratin (pegfilgrastim) and Vynpenta (avacopan). (Also see "Teva’s Ajovy & Pfizer’s Vizimpro Get EU Thumbs Up From CHMP " - Pink Sheet, 4 Feb, 2019.) (Also see "EU's CHMP OKs Major New Uses for Hemlibra, Praluent, Forxiga – And More" - Pink Sheet, 5 Feb, 2019.)
The CHMP might also recommend the suspension or withdrawal of medicines if unexpected side effects or other concerns are reported.
Work conducted by the CHMP and its working parties can lead to advice and recommendations being released after the committee's monthly meetings, including advice on harmonizing labeling for specific products across the EU, making recommendations on assessing medicines' safety, quality, manufacturing or efficacy, and settling disagreements between national regulatory authorities involved in the mutual recognition or decentralized approval procedures.
Recommendations from the CHMP’s February 2017 to January 2019 meetings are shown below.
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