Celebrex Receives Priority Review for Familial Adenomatous Polyposis Indication

Strategic Insights -

Familial adenomatous polyposis (FAP) is a rare genetic disorder characterized by the development of numerous adenomatous polyps in the colon and rectum, often associated with elevated COX-2 expression. These polyps are precursors to colorectal cancer, and left untreated, nearly all patients develop the disease by age 40-50. G.D. Searle & Co. and Pfizer Inc. collaborated on a pivotal trial evaluating the use of celecoxib, a COX-2 inhibitor, in combination with colonoscopy surveillance for the management of FAP patients. The New Drug Application (NDA) for Celebrex has received a priority review from the FDA for this new indication.

Key Takeaways:

  • The FDA has granted priority review to the NDA for Celebrex for the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP).
  • The pivotal trial, conducted in collaboration with the National Cancer Institute (NCI), evaluated the use of celecoxib in combination with colonoscopy surveillance for FAP patients.
  • Celebrex was approved for osteoarthritis and adult rheumatoid arthritis on December 31, 1998.
  • FAP is a rare hereditary condition with hundreds to thousands of adenomatous polyps in the colon and rectum developing during adolescence and early adulthood.
  • Adenomatous polyps, often expressing elevated COX-2, are considered precursors to colorectal cancer.
  • There are currently no approved drugs for FAP treatment, leaving patients with limited disease management options.
  • The FDA's priority review designation indicates the agency's willingness to expedite the review process for a potential new therapy for FAP patients.

Statistics:

  • Nearly all (~100%) patients with untreated FAP develop colorectal cancer by age 40-50.
  • Celebrex was approved for osteoarthritis and adult rheumatoid arthritis on December 31, 1998.
  • In 1998, Searle reported sales of $8.6 billion and invested $1 billion in research and development.
  • In 1998, Pfizer reported revenues of $13.8 billion and invested $2.2 billion in research and development.

Sources:

  • [G.D. Searle & Co. press release, August 30 (no year specified)]
  • [National Cancer Institute]
  • [Food and Drug Administration]
  • [Pfizer Inc.]
  • [Monsanto Company]