Biogen stock tumbled Friday after the Food and Drug Administration requested an independent review of the process that led to its recent Alzheimer’s drug approval.
Acting FDA Commissioner Janet Woodcock acknowledged the ongoing controversy surrounding the accelerated approval of the drug called Aduhelm. She requested the Office of the Inspector General review interactions between the agency and Biogen.
Biogen (BIIB) said in a statement late Friday that it would “of course, cooperate with any inquiry in connection with a possible review of the regulatory process.”
On the stock market today, Biogen stock sank 3% to 358.16. Meanwhile, shares of other Alzheimer’s-drug makers also fell. Cassava Sciences (SAVA) stock toppled 10.1% to 95.34. Shares of Cortexyme (CRTX) skidded 3.2% to 57.45. Anavex Life Sciences (AVXL) shares dipped 2.6% to 25.07.
Biogen Stock Falls On Potential Review
The request follows a Stat News report that Biogen had an off-the-books meeting with Billy Dunn, head of the FDA’s Office of Neuroscience, in May 2019.
Previously, Biogen said the drug formerly called aducanumab would fail in testing. Later, Biogen flipped that decision and said the drug actually succeeded in one final-phase test. The FDA gave Aduhelm an accelerated approval on June 7, over objections from an advisory committee.
Critics contend Biogen and the FDA appear to have had a cozy relationship leading up to Aduhelm’s approval.
FDA’s Woodcock says concerns could undermine the public’s confidence in the agency’s decision. She requested the OIG look into “whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures.”
Controversial Approval, Hefty Price
Aduhelm’s approval has been fraught with controversy, and Biogen stock has yo-yoed.
The accelerated approval is based on the idea that Aduhelm removes the buildup of plaques called beta amyloid in the brain. But experts don’t agree that will lead to a benefit on cognition. Biogen now has nine years to run a study confirming the cognitive benefit. In the meantime, Aduhelm can still hit the market.
Three members of the advisory committee that voted against recommending Aduhelm’s approval later resigned in protest.
Further, Biogen is planning to charge $56,000 for a year of maintenance treatment. That cost is well above expectations and could hurt the health care system.
Earlier this week, the FDA agreed to a narrower label for Aduhelm, allowing its use in just mildly affected patients.
So, the apparent off-the-books meeting with Dunn added another complication for Biogen stock, which has seesawed on news reports.
Split Opinions On Aduhelm
Public Citizen, a nonprofit that advocates for consumers, supported Woodcock’s “belated request” for an independent investigation.
“Such an investigation must be broad and determine when Dr. Woodcock first became aware of this collaboration and whether she ever specifically endorsed or facilitated it in any way,” Public Citizen said in a letter.
Others are more forgiving of the recent drama. On Thursday, the Alzheimer’s Association voiced support for the FDA’s decision to narrow the label for Aduhelm.
“Today’s announcement is consistent with the Alzheimer’s Association position that Aduhelm should be made available specifically to the population represented in the clinical trials where there was evidence of clinical benefit,” the association’s chief medical officer, Maria Carrillo, said in a written statement.
Despite the controversy, Biogen stock remains in the green for the year. Shares neared 500 on the approval last month.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
YOU MAY ALSO LIKE: