Could Time to Approval be Secondary? - Giora Davidai, MD

Giora Davidai, MD

I would like to discuss two projects that illuminate the same issue, what is the optimal scope and size or an NDA package.


When I worked for Glaxo Welcome I was involved in the development of a second drug for a neurological indication.  The first drug of the same class has been developed and successfully commercialized by GW several years before.  At the same time another pharmaceutical company was developing a similar drug.  We had designed a very comprehensive phase III package with the intention to sail through the FDA approval process and serve as solid basis for commercialization.  The package was filed with the FDA several months before the competition.  Needless to say we were confident we would be able to launch our drug first.  The competitive drug package was much smaller, minimalistic in scope and data. The size and content of the package enhanced our confidence for a first approval of our product.  To our surprise, FDA completed review and approved the other drug first and we came to market several months behind.  The rationale given to the competitor faster review and approval was the volume of material the FDA had to review. In spite of being approved earlier GW drug established a superior market share using the breadth of content in our larger package.


Recently, when I worked for Boehringer Ingelheim I was involved in another race to regulatory approval.  BI, and other pharmaceutical companies developed innovative drugs for a similar indication.  BI had based its application on one mega -trial with the approval of FDA.  For various reasons, including speed of approval and the aim to be first to market, our package included only one indication, and a minimalistic volume of data that centered around the mega-trial.  Indeed our drug was approved first.  We had almost 9 months market advantage.  However, with a more comprehensive NDA and much more active phases IIIb and IV, including immediate applications for additional indications, the competitor drug has established a significantly superior market share to that of BI.


Lessons learned?  Speed of approval might not necessarily be a long term advantage if it comes with a price of being far from optimal for commercialization purposes.  As Robert Ingram, than CEO of GW in US said,  “time to approval is only secondary to time to maximal market share”