Is drug repositioning surpassing new brands discovery and development?
Since US FDA added the 505(b)(2) pathway for drug approval 18 years ago, the number of approvals through this amendment has consistently increased, until 2006 when it surpassed the approvals by de novo NDA pathway, designated for proprietary drugs.
Many factors can justify this movement in the pharmaceutical industry. One of them is the risk mitigation, since filing a 505(b)(2) pathway after phase 3 has 40-70% of getting approval, compared to 10-20% when filing a de novo NDA. These has major consequences to how biotechs and pharma approach repositioning, as it also represents a threat to those whoâ€™ll have their own drugs been repositioned by their competitors.
Biotechs specialized in articulating strategies for 505(b)(2) pathway, will be talking about the opportunities and risks involved in that approach in the World Drug Repositioning Congress USA 2012, next December in DC.
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