EMA committee predicts surge in development of high-level medicines

Published: 25-Feb-2013

Most are for cancers, cardiovascular diseases and haematology


The European Medicines Agency’s committee for advanced therapies has predicted a surge in market approval applications (MAAs) for such specialist medicines.

Committee chair Christian Schneider said: ‘With the approval of the first gene therapy in 2012, the CAT is paving the way for the approval of similarly complex medicines…as more gene therapies for rare diseases, personalised medicines and nanomedicines are on their way.’

EMA last year approved a treatment for lipoprotein lipase (LPL) deficiency and the committee said: ‘While the number of MAAs for advanced therapies is still limited, the research and development pipeline is large. As a consequence, a high number of MAAs for advanced therapies is expected over the next five to 10 years.’

In 2012, 17 applications were submitted for advanced-therapy classification, with 14 receiving such certification; compared with 12 submitted and 12 adopted in 2011. A similar number is expected in 2013, said the committee. Among those advanced medicines under development, 75% are cell-based medicinal products while 25% are gene therapies – most are for cancers, cardiovascular diseases and haematology.

With small-and-medium-sized companies key developers, financial or other support should be considered, added Schneider.

‘In the current financial and economic environment, many companies would not…risk…having this kind of product in their pipeline…’

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