FDA Denies Petition to Grant Simufilam Breakthrough Designation

The FDA has denied a citizen petition to grant a breakthrough therapy designation for Cassava Science’s investigational Alzheimer’s therapy, simufilam, because the petition was submitted by an individual rather than the company.

In denying the petition submitted last October by Paul Efron, an investor in Cassava, Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research, noted that any request for breakthrough designation could only come from Cassava.

The FDA “denies your request for breakthrough therapy designation of simufilam because you are not the drug sponsor,” she wrote, adding that the Food, Drug and Cosmetic Act specifies that requests for breakthrough therapy designation must be submitted by the sponsor.

A Cassava spokesperson said the company is “broadly aware” that citizen petitions were filed in support of simufilam but that “Cassava is not affiliated with the individuals and is not connected in any way to the filings.”