‘Significant questions remain’ on approval of Biogen’s new Alzheimer’s drug, congressional committees tell FDA – Endpoints News
'Significant questions remain' on approval of Biogen's new Alzheimer's drug, congressional committees tell FDA
Two prominent House committees are digging deeper into the FDA’s cozy relationship with Biogen as it reviewed and approved its new Alzheimer’s drug Aduhelm.
While the committees were briefed by FDA on the situation in mid-July, the chairs are now telling FDA, “This information was helpful, but significant questions remain.”
The House Energy & Commerce and Oversight committee chairs are now requesting in a letter this week to acting commissioner Janet Woodcock that FDA provide very specific info by Sept. 16. The requested information includes the body of evidence upon which regulators relied to determine the use of amyloid beta plaque as a surrogate endpoint as “reasonably likely to predict clinical benefit” for Alzheimer’s disease, and what actually happened between the FDA and Biogen leading up to the approval.
While noting that the accelerated approval came despite concerns raised by the agency’s own staff and members of an adcomm, three of whom later resigned, the committees highlighted “reports of unusual coordination between FDA and Biogen” throughout the drug’s approval process. The committee chairs also noted the HHS Office of Inspector General is also officially reviewing the approval and the accelerated approval pathway.
'Significant questions remain' on approval of Biogen's new Alzheimer's drug, congressional committees tell FDA
Two prominent House committees are digging deeper into the FDA’s cozy relationship with Biogen as it reviewed and approved its new Alzheimer’s drug Aduhelm.
While the committees were briefed by FDA on the situation in mid-July, the chairs are now telling FDA, “This information was helpful, but significant questions remain.”
The House Energy & Commerce and Oversight committee chairs are now requesting in a letter this week to acting commissioner Janet Woodcock that FDA provide very specific info by Sept. 16. The requested information includes the body of evidence upon which regulators relied to determine the use of amyloid beta plaque as a surrogate endpoint as “reasonably likely to predict clinical benefit” for Alzheimer’s disease, and what actually happened between the FDA and Biogen leading up to the approval.
While noting that the accelerated approval came despite concerns raised by the agency’s own staff and members of an adcomm, three of whom later resigned, the committees highlighted “reports of unusual coordination between FDA and Biogen” throughout the drug’s approval process. The committee chairs also noted the HHS Office of Inspector General is also officially reviewing the approval and the accelerated approval pathway.