science
FDA to Review Compounding Pharmacies’ Peptide Manufacturing; Alzheimer’s Drug Benefits Under Review
The FDA will hold an advisory panel meeting to consider allowing compounding pharmacies to produce certain peptides. A recent review of Alzheimer’s drugs found limited clinical benefits, though some experts noted differences among the drugs studied. Additionally, a report indicates drug prices have risen despite prior pricing agreements.
Apr 16, 9:15 AM·1m read1 source
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A review published recently assessed the clinical benefits of new Alzheimer’s drugs developed over the past two decades. The review focused on seven monoclonal antibody drugs targeting amyloid proteins, which form plaques in the brains of Alzheimer’s patients. The overall conclusion was that the clinical benefit of these drugs is minimal.
However, some experts criticized the review’s methodology, stating that it grouped drugs with different mechanisms and outcomes together. The experts noted that data from the two most recent drugs studied — Leqembi and Kisunla — showed they could slow cognitive decline, which led to U.S. regulatory approval and made them the only anti-amyloid drugs available to patients.
A report released by Senate Democrats finds prices have continued to climb — in some cases, sharply. The report found that companies that signed drug pricing deals have raised the cost of hundreds of medications and launched new ones at an average price of $353,000 a year.
The price hikes include expensive gene therapies, cancer medications, and multiple sclerosis drugs. The report also said the companies that signed deals have made huge profits during the second term in office — a combined $177 billion, up from $107 billion the year before.
These developments highlight ongoing discussions about drug pricing, regulatory oversight of compounded medications, and the evaluation of new treatments for Alzheimer’s disease.
