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FDA Advisory Committee Preparation: Drug Approval

Situation

A start-up biopharmaceutical company with no marketed drugs, was trying to get its first product through the FDA approval process and through the market. The therapy was for an orphan indication and the class of drugs was suspected of potentiating existing cancers. After two patients died of cancer in the clinical trial program, the FDA called an advisory committee meeting to determine whether the drug should be approved.

Solution

3D helped develop a strategy and prepared presenters to emphasize: the huge unmet need among this orphan population; the therapy’s efficacy; and the company’s plan to monitor and address the potential cancer risk. We worked closely with the company and doctors to coordinate a poignant public comment period in which patients spoke of their condition and the need for the therapy, and prepared the team to clearly articulate data on a condition and a treatment that were not well-understood by most advisory committee members.

Results

The FDA advisory committee voted 12-0 recommending approval. The FDA approved the drug 9 weeks later.

Learn more about our FDA Advisory Committee Drug Approval Preparation Strategies