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Pharmaceutical industry

FDA Advances Review of Aptosyn(TM) (Exisulind) for Familial Adenomatous Polyposis

Strategic Insights

— 2 min read

Cell Pathways, Inc. (CPI) has received a significant update from the U.S. Food and Drug Administration (FDA) regarding the review of their New Drug Application (NDA) for Aptosyn(TM) (exisulind) to treat Familial Adenomatous Polyposis (FAP). The FDA plans to evaluate the NDA without requiring input from its Oncologic Drugs Advisory Committee (ODAC), paving the way for potential approval of the drug.

FAP is a rare hereditary condition characterized by the development of hundreds to thousands of adenomatous polyps in the colon and rectum during adolescence and early adulthood. If left untreated, virtually all patients with FAP develop colorectal cancer by age 40-50. There are currently no approved medical treatments for the prevention of precancerous polyps in FAP patients.

Cell Pathways, headquartered in Horsham, Pennsylvania, is a development-stage pharmaceutical company focused on developing and commercializing products to prevent and treat cancer. The company has submitted supplemental clinical data in October, which the FDA has agreed to review in further detail.

Key Takeaways:

  • Cell Pathways, Inc. (CPI) has submitted a New Drug Application (NDA) for Aptosyn(TM) (exisulind) to treat Familial Adenomatous Polyposis (FAP).
  • The FDA plans to evaluate the NDA without requiring input from its Oncologic Drugs Advisory Committee (ODAC).
  • The FDA has requested to meet with CPI in late January to facilitate review of CPI's supplemental clinical data submitted in October.
  • The FDA will subsequently review those data in further detail and have an end-of-review meeting with CPI to discuss any matters that remain to be addressed.
  • Aptosyn(TM) (exisulind) has shown consistent sustained reductions in polyp formation in FAP patients over long periods of time.
  • FAP is a rare hereditary condition characterized by the development of hundreds to thousands of adenomatous polyps in the colon and rectum during adolescence and early adulthood.
  • If left untreated, virtually all patients with FAP develop colorectal cancer by age 40-50.

Statistics:

  • The FDA plans to review Aptosyn(TM) (exisulind) data in further detail.
  • The oncologic Drugs Advisory Committee (ODAC) did not identify any additional issues that would require further input from ODAC.
  • Patients with FAP have a high risk of developing colon cancer (vulnerable to cancer, approximately 40-50 years).
  • Hundreds to thousands of adenomatous polyps develop in the colon and rectum during adolescence and early adulthood.

Sources:

  • Cell Pathways, Inc. press release, "FDA to Evaluate Aptosyn(TM) (Exisulind) NDA without ODAC Input", January 11, 2000.
  • Cell Pathways, Inc. website, http://www.cellpathways.com.
  • Food and Drug Administration (FDA) regulations and guidelines.

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