European CHMP Opinions and MAA Updates
This is an 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.
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Janssen is the latest big pharma company to gain an approval for a new oral multiple sclerosis therapy in the EU, enhancing the competitiveness of the marketplace, and giving more choice for patients.
New treatments for congenital adrenal hyperplasia and relapsing forms of multiple sclerosis are among five drugs recommended for pan-EU approval this month. In addition, harmonized EU advice has been issued for Celltrion’s monoclonal antibody COVID-19 treatment.
EU marketing authorization applications for 12 products, including Skycovion, trastuzumab duocarmazine, alpelisib and sparsenta, are now being evaluated by the European Medicines Agency.