Europe – Amid pandemic, EMA’s 2020 authorizations ticked upward

Despite the pandemic, the European Medicines Agency (EMA) issued many more positive recommendations for human medicines in 2020 than in the previous year, according to a new report from the agency highlighting the year’s regulatory activities.

In 2020, 97 new medicines were recommended for authorization by EMA; of these, 39 contain a new active substance (NAS). In 2019, EMA issued 66 positive opinions for medicines, 30 of which contained a NAS. The total numbers of new recommendations include conditional marketing authorizations such as the ones issued for the COVID-19 treatment Veklury (remdesivir) and Comirnaty, the COVID-19 vaccine co-developed by Pfizer and BioNTech.

The European regulator issued a negative opinion for Gamifant (emapalumab-Izsg), a drug approved by the US Food and Drug Administration (FDA in 2019 to treat patients with primary hemophagocytic lymphohistiocytosis. EMA also gave a thumbs down to Turalio (pexidartinib), which the FDA also approved in 2019 to treat a rare joint tumor…