FDA Applies a Presumption in Favor of NCE Status for Pancreatic Enzyme Products

By Kurt R. Karst –      

A few months ago after FDA’s approval of an NDA for the Pancreatic Enzyme Product (“PEP”) CREON (pancrelipase) (amylase; lipase; protease) we queried whether FDA might apply a presumption in favor of New Chemical Entity (“NCE”) status for all PEPs, such that each drug would be granted a 5-year period of exclusivity.  There seemed to be good reason to conclude that FDA would presume NCE status for each PEP; however, it was not until earlier this week that FDA made public its exclusivity decision.

FDA stated its “presumption in favor of NCE status” policy in 2005 in the context of the Agency’s approval of various non-recombinant hyaluronidase drug products.  In the case of hyaluronidase, uncertainty arose from the fact that such drug products are complex proteins that are not fully characterized.  FDA stated that:

Generally, if the Agency has insufficient information to know whether a product contains a previously approved active moiety, the applicant would be required to submit an NDA containing substantial clinical safety and efficacy data.  These data requirements could reasonably be expected to be comparable to those that would be needed for approval of an NCE.  Under the presumption, if it is not known whether a product contains a previously approved active moiety, the product also would be treated as an NCE for marketing exclusivity purposes, and, accordingly, granted 5-year exclusivity.  [(emphasis added)]

In the case of PEPs, FDA had previously stated that given their complexity “it is unlikely that currently available physiochemical and biological analytical tools would be able to demonstrate that the active ingredients in [PEPs] from two different manufacturers are the same.”  So, when FDA approved another PEP in August 2009 – ZENPEP (pancrelipase) (amylase; lipase; protease) – it stood to reason that FDA determined that both recently approved PEPS – CREON and ZENPEP – would each be granted 5 year exclusivity in accordance with FDA’s “presumption in favor of NCE status” policy.  But it was not until FDA published its latest Orange Book Cumulative Supplement (pages A-32-33) that the decision to grant NCE exclusivity with respect to each product became public. 

There are still pending at FDA a couple of decisions concerning NCE exclusivity, including for VERAMYST (fluticasone furoate) Nasal Spray and VYVANSE (lisdexamfetamine dimesylate) Capsules.  FDA is expected to issue a ruling concerning VYVANSE later this month.