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EMA approves more new active substances in 2018, but total recommendations fall

Published on 14/01/19 at 10:28am

2018 was a strong year for European approvals according to the EMA; the regulator has recently released its Human medicines highlights 2018, revealing key insights on the progress it and achievements it made throughout the past 12 months.

The report indicates that a total of 84 positive opinions were made during the period – a slight fall from 2017’s 94, but this figure includes the approval of 42 new active substances, which is an improvement on 35 the previous year and the highest for four years. Exactly half of these were orphan medicines, while the total number of negative opinions fell to five, with 10 application withdrawals.

Three of the year’s approvals were designated as ‘Advanced therapy medicinal products’, and included two CAR-T therapies – Novartis’ Kymriah and Gilead/Kite’s Yescarta – and gene therapy Luxturna, Spark Therapeutics’ and Novartis’ drug for an inherited condition leading to vision loss.

Reflecting industry trends, oncology saw the greatest number of approvals with a total of 23, followed by Infections and Neurology with 11 and 10 respectively.

The achievements are made even more significant considering the European agency has faced additional pressures throughout the year to efficiently transfer operations from London to its new home in Amsterdam, which it is required to do before the UK’s exit from the EU on 29 March 2018.

However, despite these successes, the agency’s performance still paled in comparison to its counterpart in the US, the FDA, which managed to approve a total of 59 new molecular entities over the same period – a record-breaking achievement for the regulator.

Matt Fellows

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