Regulators, Rejections and the Rise of AI in U.S Drug Approval
Ulf Hannelius; CEO, Diamyd Medical
"Interesting times" may well be the understatement of the year. For life science companies entering the U.S. market, the approval process is rarely linear guided not just by science, but by patience, regulatory insight, and the occasional “No” that ultimately becomes a historic “Yes.”
This was a key message when Diamyd Medical’s CEO Ulf Hannelius spoke at SwedenBIO’s seminar ” Growing your business in the US” in Stockholm recently. In an insightful presentation, he shared how initial challenges and differing opinions with the FDA sparked a productive dialogue and clarification process, ultimately leading to a groundbreaking Fast-Track Designation—paving the way for a potential accelerated approval in type 1 diabetes.
At first glance, it’s a familiar tale of regulatory perseverance. But there’s a larger shift underway—one that could reshape drug development over the next decade: the FDA’s growing integration of artificial intelligence.
Just days before the Sweden Bio event, the FDA launched Elsa, a generative AI tool designed to assist in reviewing protocols, summarizing safety data, and identifying inspection priorities. The broader rollout is scheduled for June 30, 2025, marking more than a technical upgrade—it signals a transformation in how the agency handles complexity and reviews evidence.
For companies like Diamyd Medical, the implications are double-edged. On one hand, clear and well-supported applications may progress faster. On the other, the standards for structure and consistency may rise sharply, as human review merges with algorithmic analysis.
Regulators are not the enemy—but they are evolving quickly. Designations like Fast Track and Orphan Drug now offer more than credibility; they create openings for strategic discussion. And with FDA’s Elsa, those discussions may begin before a single meeting is scheduled.
Of course, AI also introduces risk. It can highlight strong submissions—but it can just as easily flag flaws or amplify ambiguity. If algorithms are reviewing the same dense documents once left to fatigued humans, companies must now communicate with both audiences: the reviewer and the machine.
Perhaps this is not just a new chapter for the FDA, but for every biotech with U.S. ambitions. Regulatory approval has always blended science with storytelling. Now, it must also speak AI.
Welcome to the Elsa era. The review clock may still say 60 days, but the game is already moving faster.
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The U.S. FDA has granted Swedish biotech company Diamyd Medical Fast Track- and Orphan Drug Designations for the treatment of Type 1 Diabetes and the prevention of the disease in individuals —special designations that help speed up the approval process. Its lead candidate, Diamyd®, is now in Phase 3 clinical trial in both Europe and the U.S., targeting individuals recently diagnosed with the disease who carry a specific genetic profile (HLA DR3-DQ2).
Early results are expected in less than a year, marking an important milestone in the quest to preserve the body’s own insulin production and change the course of Type 1 Diabetes.
Diamyd Medical will be at the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago, June 20–23, 2025, offering a chance to meet the team behind the novel precision medicine approach being developed.
Related links mentioned in the text:
SWEDENBIO event: https://www.youtube.com/watch?v=72lyGW95W48
ADA i Chicago: https://professional.diabetes.org/scientific-sessions
