Cancer and orphan drugs drive increase in US NME approvals
Until 2010, the number of New Molecular Entities (NMEs) approved by the US Food and Drug Administration had been stagnating despite higher investments in drug development by the biopharma industry, notes the latest New Drug Approval Report 2013, prepared by Switzerland-based HMB Partners. In 2011 and in 2012, however, approval numbers increased significantly, driven - among other factors - by the high number of cancer and/or orphan drugs approved.
Revenue potential (peak sales estimates) of new drugs approved in 2012 has risen to $30.4 billion (up from $22.6 billion for drugs approved in 2011). The respective number for 2010 was $17.5 billion. Both in 2011 and in 2012, 10 new drugs have blockbuster potential, ie, could reach more than $1 billion of sales.
Some other noteworthy findings from the HBM analysis:
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