The aducanumab saga continues. The Food and Drug Administration has delayed a decision on licensing by three months, pushing the deadline from March to June 7. In a press release, the drug’s sponsor, Biogen, said the FDA had requested more information, and in response Biogen submitted “additional analyses and clinical data.” The FDA considered the addition to be a major amendment to the biologics licensing application, necessitating more review time.
The aducanumab tale was already full of surprises, going from futility on its two Phase 3 trials to their resurrection (Mar 2019 news; Oct 2019 news; Dec 2019 conference news). Biogen submitted a licensing application to the FDA last year, and has also applied for marketing approval in Europe and Japan (Jul 2020 news; Aug 2020 news). The FDA application ran into headwinds at an advisory committee meeting, prompting speculation the application would be rejected (Nov 2020 news; Nov 2020 news).
It is unclear what additional data Biogen submitted. The company declined to share details with Alzforum. Biogen continues to gather data on aducanumab’s safety and effectiveness in the EMBARK open-label extension trial. This type of data is not placebo-controlled, and is not usually used as the basis for licensing decisions.
Researchers were mystified, as well. “I have no idea what the FDA delay of the Biogen aducanumab decision means, nor do any of my colleagues who usually have insightful opinions on such matters,” David Knopman at the Mayo Clinic in Rochester, Minnesota, wrote to Alzforum. Russell Swerdlow at Kansas University Medical Center in Kansas City wrote, “It will be interesting to see how any new data impacts the very negative FDA statistical analysis.”
Bruno Imbimbo of Chiesi Pharmaceuticals in Parma, Italy, wondered if the recent change in FDA leadership, where Janet Woodcock took over as acting commissioner from Steven Hahn, would affect the licensing decision. “Based on the enormous impact the FDA’s final decision on aducanumab will have on the U.S. health care system, I believe the three-month postponement of the feedback is a positive development of this delicate scientific and patient health care story,” Imbimbo wrote to Alzforum.
Industry analysts speculated that the delay might raise the odds of approval. “Based on our analysis of prior Prescription Drug User Fee Act (PDUFA) extensions, we think minor delays typically lead to an approval,” analysts at New York-based financial analysis firm Jefferies told the industry press. If so, aducanumab could be approved based on data not seen by the advisory committee. Biogen shares jumped 9 percent the day of the announcement, but have now dropped back to previous levels.—Madolyn Bowman Rogers
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