EMA overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.

EMA overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.

On January 2020, the European Medicines Agency (EMA) published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use.

In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a new active substance which had never been authorised in the EU before. In particular, 7 orphan medicines and 1 Advanced therapy medicinal (Zynteglo for the treatment of beta thalassaemia in patients 12 years and older) product have been authorized. Moreover, the report includes an infographic with a selection of medicines that represent significant progress in their therapeutic areas. Sixty extensions of indication were recommended in 2019. The extension of the use of a medicine that is already authorised for marketing in the EU can also offer new treatment opportunities for patients. Extensions of indication included Victoza to for the treatment of children and adolescents aged ten years or older with type 2 diabetes and Dupixent as an add-on maintenance treatment for patients 12 years and older with certain forms of severe asthma. Finally, the Committee for Medical Products for Human Use (CHMP) adopted a negative opinion for four medicines in 2019.

March 3rd, 2020|