Medicines agency sees more drugs for rare diseases

The European Medicines Agency received 36 per cent more applications for approval of medicines treating rare diseases in 2012 compared to 2011, according to the EMA’s annual report.

The agency received 96 initial marketing authorisation applications for human medicines in 2012, compared with 100 in 2011 and 91 in 2010. Of these, 19 referred to orphan medicines, up from 14 in 2011 and 12 in 2010. Orphan medicines are used to treat rare conditions and receive competition protection once they reach the market.

A large amount of applications for rare diseases medicines came from small businesses, the report showed. While small and medium enterprises made only about 30 per cent of the total applications submitted to the EMA in 2012, 68 per cent of the applications for orphan medicines came from small and medium enterprises in 2012, up from 28 per cent in 2011.