SKIMMERS SUMMARY:
- Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product.
- The FDA’s recent approval of aducanumab (Aduhelm) shows just how badly the agency has failed the public.
- In late April, the FDA’s Oncologic Drugs Advisory Committee reviewed six accelerated approvals — a provisional pathway — involving a group of cancer immunotherapies where clinical trials had failed to confirm that the drugs extended survival or improved quality of life. Yet, in four of the six cases, the advisory committee voted to keep the accelerated approvals intact. (source: Medpage)
- In response to the FDA’s approval, three members of the Peripheral and Central Nervous System Drugs Advisory Committee who opposed approval of the drug quit the panel in protest.
- Physicians are signaling that they now want to see the “complete date” regarding new drug approvals.
