In Rebuke Of FDA, Panel Of Experts Refuses To Endorse Alzheimer’s Drug
The Food and Drug Administration had given aducanumab a glowing appraisal. However, 10 of the 11 panelists voted that the data provided by Biogen’s one positive study was not enough to demonstrate that the drug could slow cognitive decline. The other panelist voted “uncertain,” Stat reports.
Expert Panel Votes Down Biogen’s Alzheimer’s Drug, And Rebukes FDA
A panel of outside experts resoundingly concluded Friday that clinical data did not support the approval of Biogen’s much-watched Alzheimer’s drug, aducanumab, while providing a rebuke to the Food and Drug Administration, whose reviewers had given the medicine a glowing appraisal. (Herper, Feuerstein and Garde, 11/6)
The New York Times:
F.D.A. Panel Declines To Endorse Controversial Alzheimer’s Drug
In a seven-hour virtual meeting on Friday, the panel showed pointed skepticism, which contrasted markedly with a presentation by Dr. Billy Dunn, director of the Food and Drug Administration’s office of neuroscience, who said that “the evidence supporting its approval appears strong.” Overwhelmingly, the panel members disagreed. (Belluck, 11/6)
In other pharmaceutical news —
Experts Say COVID-19-Affected Drug Market Rebounding
As the first surge of the COVID-19 pandemic hit in the spring, the headlines began heralding the need for more robust and secure supply chains and warning about critical drug shortages. At that point, there was only so much that pharmaceutical companies could do, but a recent analysis by the Healthcare Distribution Alliance, the national organization representing primary pharmaceutical distributors, provided a positive perspective on the industry's performance during the pandemic's first 90 days. The report, titled "The First 90 Days: US Biopharmaceutical Finished Goods Supply Chain Response to COVID-19," was prepared by Deloitte and highlighted the shift of drug distributors' operations owing to COVID-19. It called the supply chain "resilient and effective." Even so, the report acknowledges that more actions are needed by the industry to address the next ripple effect from the pandemic. (McLemon, 11/6)
AstraZeneca's Brilinta Won Its Coveted Stroke-Prevention Nod. Will It Be Enough To Boost Long-Term Sales?
A few months ago, AstraZeneca’s Brilinta added a new U.S. indication to reduce the chance of a first heart attack or stroke in certain high-risk patients. Now, the blood thinner has won a green light to prevent another stroke in patients who already suffered a mild-to-moderate one. Specifically, the FDA approved Brilinta alongside aspirin to reduce the risk of another stroke in two groups of stroke patients: those with acute ischemic stroke who score at or below 5 on the National Institutes of Health Stroke Scale and those with a high-risk transient ischemic attack, also known as mini-stroke, AstraZeneca said Friday. (Liu, 11/6)