December 30, 2022
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A congressional inquiry found the FDA’s interactions with Biogen to be “unusual and non-protocol” and that the two “inappropriately cooperated on documentation” prior to Aduhelm’s approval for Alzheimer’s disease. ” it turned out.
Additionally, according to the executive summary of the study, Biogen, the maker of Aduhelm (aducanumab), initially set an “unreasonably high price” for the drug in order to “make history” for the company. According to internal documents, Biogen initially priced Aduhelm at $56,000 annually “despite its lack of demonstrated clinical benefit.”
The findings of the investigation were released on Dec. 29 by the staff of the US House of Representatives’ Oversight and Reform Committee and the Energy and Commerce Committee.Chairman of the Energy Commerce Commission Frank Parone Jr. (DN.J.) has released a statement regarding the report.
“This report chronicles the extraordinary FDA review process and corporate greed that preceded the FDA’s controversial decision to grant accelerated approval to Aduhelm,” said Pallone. “While we all support the search for new treatments and cures to combat devastating diseases like Alzheimer’s disease, the FDA’s independence and scientific rigor over protocols guarantee it.” convenience must not be a priority, and patient safety and efficacy must remain at the heart of our country’s regulatory review process.”
Aduhelm was granted accelerated approval by the FDA on June 7, 2021. On the same day, the FDA called for a federal investigation into the approval of the Biogen treatment.
A congressional study found that the FDA and Biogen held at least 115 meetings, phone calls and email exchanges over a 12-month period. More than 40 working group meetings were held, according to the report, but not all were properly documented.
According to a congressional investigation, “FDA’s own internal review of the FDA’s approval process for Aduhelm found the degree of cooperation between FDA and Biogen to be atypical and, in some respects, beyond the norm.” It turned out.”
Additionally, the report says the FDA “suddenly” changed the course of the traditional approval process, accelerating Aduhelm’s approval after just three weeks of review. Authorities initially considered him under the conventional approval process used for most drugs.
The investigation found that the move to accelerated approval only occurred after the April 7, 2021 FDA expert meeting, which “brought unfavorable feedback on Aduhelm’s previous approval.” On April 28, 2021, the FDA notified Biogen that Aduhelm will be considered for accelerated approval.
The report also says the FDA has approved Aduhelm for a wide range of indications, and Biogen has, despite the lack of clinical data. The agency approved He Aduhelm for the treatment of “Alzheimer’s patients.” This is a much broader population than Biogen studied in clinical trials, and included people with mild cognitive impairment and mild dementia.
In 2023, the FDA plans to meet and discuss two other treatments for Alzheimer’s disease and related dementias. Biogen and Eisai are developing another Alzheimer’s drug, lecanemab, which reduced cognitive decline by 27%. Eli Lilly recently announced that its treatment, donanemab, met its primary and secondary endpoints in a Phase 3 trial.
Aduhelm investigation. https://oversight.house.gov/sites/democrats.oversight.house.gov/files/Final_Document_Packet-Biogen_UPDATED_Redacted.pdf. Published December 29, 2022. Accessed 30 December 2022.
FDA expedites approval of drugs for Alzheimer’s disease. https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug. Published June 7, 2021. Accessed December 30, 2022.
Lilly shares positive data for donanemab in the first active controlled trial in early symptomatic Alzheimer’s disease. https://investor.lilly.com/news-releases/news-release-details/lilly-shares-positive-donanemab-data-first-active-comparator. Published November 30, 2022. Accessed 30 December 2022.
Maloney and Pallone released a staff report on the review, approval and pricing of Biogen’s Alzheimer’s drug Aduhelm. https://energycommerce.house.gov/newsroom/press-releases/maloney-and-palllone-release-staff-report-on-review-approval-and-pricing-of. Accessed 30 December 2022.
The cost of Aduhelm’s approval: An investigation into the FDA’s unusual review process and Biogen’s aggressive launch plans. https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Final%20Aduhelm%20Report_12.29.22.pdf. Published December 29, 2022. Accessed 30 December 2022.