EMA Approves 93 New Drugs in 2015

The European Medicines Agency stepped up its reviews in 2015, signing off on 93 drugs — 11 more than in 2014.

But fewer of these approved drugs contained new active substances, with 39 recommended for marketing authorization to the European Commission versus 41 in 2014.

In 2015 the EMA recommended approval for 14 new cancer therapies, six of which it classified as innovative treatments. By contrast, the EMA signed off on only eight cancer drugs in 2014.

Last year also saw a slight bump in recommendations for orphan drug approval, with 18 cleared by EMA versus 17 in 2014. Accelerated assessment numbers dropped in 2015, with five recommended by the EMA versus seven in 2014. The EMA recommended three drugs for conditional marketing approval in 2015, versus two in the previous year.

The 2015 report notes that five applications for drug approval were withdrawn prior to the EMA making a recommendation, compared with six in 2014. In addition, the EMA gave unfavorable recommendations for four products in 2015 versus three in 2014.

Read the 2015 report here: www.ema.europa.eu/docs/en_GB/document_library/Other/2016/01/WC500199664.pdf.