Cereno Scientific and Racura Oncology spoke to DDN Assistant editor Allison Whitten about drug repurposing, in light of the recent FDA announcement that it had launched an initiative seeking to target unmet needs across many conditions. 

“This initiative is long overdue, but like all new FDA initiatives it will be the details that matter,” Daniel Tillett, CEO of Racura Oncology, told DDN. “The FDA recognizes that there is little or no commercial incentive to pursue labeling changes for drug repurposing if a drug is off patent. Until there is a viable mechanism to recoup the costs involved in running repurposing studies, commercial interest in drug repurposing will remain muted.”

While Sten Sorensen, CEO of Cereno Scientific, commented that the new FDA initiative could help their clinical program move forward in two main ways. “A more structured and supportive regulatory framework for repurposed drugs has the potential to streamline interactions with the FDA, reduce perceived development risk, and accelerate the path toward approval,” he said. “From a partnering perspective, the initiative also matters. Big pharma, when evaluating transactions, views repurposed drugs as a risk, and a clear regulatory signal of support from FDA for repurposed drug development improves the attractiveness of assets like ours in those conversations.”

However, Sorensen added that “demonstrating disease-modification in a complex disease like PAH requires robust, long-duration clinical data, and that takes time and resources regardless of the regulatory environment. Generating the kind of evidence that satisfies both regulators and potential partners remains the central challenge, and one we are addressing head-on through the design of our global Phase 2b study.”

Read the full article here.