New Medicines Recommendations Up in 2021, EMA States

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The agency recommended 53 new active substances in 2021, up 35% from 2020.

On Feb. 15, 2022, the European Medicines Agency (EMA) released its overview of key recommendations made in 2021. There were 92 medicines recommended for marketing authorization in 2022, with 53 being active substances not previously authorized in the European Union. New active substance recommendations were up 35% over 2020. Five negative opinions were given out, and seven applications were withdrawn during the year.

There were four COVID-19 vaccines recommended in 2021, as well as five treatments. EMA also approved 33 new COVID-vaccine manufacturing sites in 2021, which increased vaccine manufacturing capacity and supply.

The majority of drugs (20) were recommended to treat cancer, and more than 12 medicines were recommended for the treatment of neurological conditions. Other conditions that received treatment recommendations included immunology/rheumatology, endocrinology, cardiovascular, dermatology, ophthalmology, pneumology, among others.


Orphan drugs approved by EMA in 2021 included Pemazyre for the second-line treatment of advanced or metastatic bile duct cancer, Imcivree to treat obesity, Voxzogo to treat achondroplasia, Bylvay to treat progressive familial intrahepatic cholestasis, and Koselugo to treat pediatric patients with neurofibromatosis type 1 plexiform neurofibromas.

Source: EMA