Analysts at Jefferies expect Biogen to file for approval of aducanumab in Alzheimer’s disease within weeks. Biogen, for its part, is keeping mum about its plans, stating only that it is preparing modules of the common technical document for submission to the FDA.
With Biogen having shared the analyses it thinks will support approval of aducanumab last year, the focus has shifted to the timing of the filing and a search for clues about the FDA’s position. The annual J.P. Morgan Healthcare Conference in San Francisco provided analysts and investors with an opportunity to probe Biogen, but the company gave little away.
Asked about the filing, Biogen Chief Medical Officer Al Sandrock said: “We’ve been constructively engaged with FDA, basically since last June. It’s a matter of preparing all the different modules of the common technical document and submitting them to FDA as rapidly as possible.”
The lack of concrete information from Biogen has left analysts to speculate. Michael Yee and his colleagues at Jefferies said their “best estimate and interpretation” is that Biogen will make the filing “within weeks,” although even that tentative prediction came with the caveat that details “are very much unclear.” Given the tightrope Biogen is walking, its secrecy is explicable.
“[Biogen] is clearly taking a strategic (and perhaps smart) approach to not say anything to jeopardize discussions,” the analysts wrote in a note to investors.
Sandrock and his colleagues are being similarly tight-lipped about other aspects of the effort to get aducanumab to market. Biogen is now in talks with regulators in Europe and Japan but declined to be drawn in on how their views on the data compare to those of the FDA, saying only that the discussions have been “positive.”
The next potential pointer toward regulatory attitudes about the data will come when the FDA decides to put aducanumab in its standard or priority review pathway. Yee expects investors to interpret acceptance of aducanumab for priority review as a positive for the drug’s prospects, making it a stock-moving event.
Asked about how the complexity of the data set may affect the chances of a getting priority review, Sandrock said: “We’re in a very unique situation. I’ve never been in one quite like this. To go from futility to a filing is unique. The level of constructive engagement we’ve had, essentially since the first type C meeting in June, is pretty unusual. I would leave it at that.”