SKIMMERS SUMMARY:

  • Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. Source: Fierce Pharma
  • If that enthusiasm pans out in the long run, it could mean at least 300,000 patients taking the drug, or $10 billion to $15 billion in peak Aduhelm from U.S. sales alone, which is above consensus estimates of around $7 billion to $8 billion, the team said.
  •  One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. history.” Source: STAT News
  • Our healthcare system can’t continue to support drugs that don’t have good clinical outcomes behind them.

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.

QUICK READ: The Federal Drug Administration’s Office of Prescription Drug Promotion (OPDP) on Wednesday issued the first warning letter specific to paid-search ads since 2014. The FDA said that the search results did not include any fair balance. This is an example of how out of date the FDA’s Office of Prescription Drug Promotion (OPDP) really is.