We know that 505(b)(2) drug development is chosen because it is lower cost, lower risk and faster than traditional new drug development and offers the potential of greater ROI than generics. But, it is not without any risks.
On 3/06/2009, Takeda announced “that although the alogliptin NDA was filed prior to issuance of FDA’s December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.” In essence, FDA changed the rules during the NDA review and Takeda must do additional studies to meet these new requirements.
Rule changes can happen during any NDA review. Takeda or its CRO, PPD both were likely aware of this new guidance, which was developed in FDA’s response to the observed heart attacks linked to GSK’s rosiglitazone (Avandia).
Camargo is involved in many drug development projects at many FDA divisions which allows us to be current on proposed changes at the Agency. Nevertheless, no one can anticipate all changes and know whether the Agency will apply them to pending NDA programs or submissions.