The US Food and Drug Administration has scaled back the prescribed uses for a new Alzheimer’s drug, now limiting it to “mild” dementia cases, after several health advisers resigned in protest over a rushed approval process.
Drug developer Biogen announced the new prescribing label on Thursday, noting that aducanumab – also known by its trade name, Aduhelm – should be given only to those in the early stages of Alzheimer’s.
“Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials,” the company said in a press release.
Though the FDA’s initial approval last month made no distinction between varying levels of disease, Biogen said that it has “no safety or effectiveness data” for other stages of the illness. The company’s head of R&D Alfred Sandrock added: “we submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials.”
The food and drug regulator drew intense criticism after giving the green light to Aduhelm, including from within the FDA itself. Three scientists on the advisory panel tasked to review the drug resigned, arguing the “last minute” approval was based on flimsy evidence. None of the committee’s 11 members voted to approve the medication, with 10 in opposition and one voting “uncertain.”
While the committee voiced concerns that the available data did not prove Aduhelm could slow cognitive decline – also warning of potentially serious side effects, such as brain swelling – the FDA authorized the drug regardless. Adviser Aaron Kesselheim, the third to leave his post, condemned the move as the “worst drug approval decision in recent US history.”
Clinical trials for Aduhelm were initially halted in 2019 after it did not prove effective, but Biogen later collected new data and re-analyzed its previous findings, telling the FDA it had better results when used in higher doses.
The FDA’s decision to give Aduhelm another look has raised questions about Biogen’s ties with federal regulators. According to a lengthy exposé published by Stat last month and based on interviews with more than a dozen officials, company executives and scientists, Biogen arranged a ‘quiet’ meeting with FDA Alzheimer’s drug czar Billy Dunn after Aduhelm’s initial rejection in 2019. Soon after the undocumented sit-down – which may have violated FDA protocols requiring such meetings to be recorded – the agency began reconsidering the controversial dementia drug, Stat reported.
Lawmakers have also joined in criticism of the FDA over Aduhelm’s accelerated approval. Rep. Katie Porter, a California Democrat, demanded a probe into the decision on Thursday, suggesting it was based on a “cozy” relationship between the regulator and Biogen rather than promising trial results.
The fast-track approval process should be used when a drug shows promise, not as a backup when test results are too lackluster for the regular process. Cozy relationships—not science—may have led to Aduhlem's approval, so I'm calling for an investigation.https://t.co/kMt3SBVgho
— Rep. Katie Porter (@RepKatiePorter) July 8, 2021
Senators Bill Cassidy (R-Louisiana) and Elizabeth Warren (D-Massachusetts) have also called for a hearing on Aduhelm and the effects it might have on the Medicare program, citing its high list price at $56,000 per year. Senator Joe Manchin (D-West Virginia), meanwhile, urged President Joe Biden to oust acting FDA commissioner Janet Woodcock over the Aduhelm approval.
As controversy over the drug rages on, the FDA has ordered a follow-up confirmatory study to prove that Aduhelm really works as intended, with Biogen noting that continued approval will depend on its findings. However, the regulator will not require a final report from Biogen until 2030, according to an FDA approval letter, meaning it could be nearly a decade before a verdict is in. In the meantime, the drug, though now limited to mild dementia cases, appears slated to remain approved.
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