Roche’s Alzheimer’s drug fails long-term trial

A study of the drug crenezumab showed that it failed to prevent the progression of Alzheimer’s disease in a Colombian community at serious genetic risk of developing the disease. Other pharma news includes illegal drug reimbursement programs, Walgreens and the diversity of drug trials, and more.

USA Today: Closely Watched Alzheimer’s Study Fails to Prevent Disease Progression

Alzheimer’s disease drug crenezumab did not slow or prevent cognitive decline in a long-term study of Colombian families with a genetic mutation that puts them at almost certain risk of developing the disease which steals the mind. The 252-person study tested whether pharmaceutical giant Roche’s antibody crenezumab could slow or stop the disease if participants took the drug before problems with memory or thinking surfaced. The drug did not demonstrate a significant benefit in tests measuring cognitive abilities or memory function in study participants, Roche said in a press release Thursday. (Alltucker, 05/16)

The New York Times: New Alzheimer’s Drug Trial Reports Disappointing Results

In the trial, 169 people with the mutation received either a placebo or the drug, crenezumab, produced by Genentech, which is part of the Roche group. Another 83 people without the mutation were given the placebo to protect the identity of people at risk of developing the disease, which is heavily stigmatized in their communities. Trial researchers hoped that intervening with a drug years before problems with memory and thinking set in could keep the disease at bay and provide important insights into treating the most common type of Alzheimer’s that doesn’t. is not due to a single genetic mutation. (Belluck, 6/16)

Stat: Roche Alzheimer’s treatment fails to slow cognitive decline in patients

The study was notable because it recruited people from an extended family in Colombia diagnosed with autosomal dominant Alzheimer’s disease caused by a mutation in a gene called presenilin 1 E280A. Study participants entered the study before showing any signs of illness, hoping that regular infusions of crenezumab would slow or prevent the onset of cognitive decline and memory loss. This inherited, early-onset form of Alzheimer’s disease is relatively rare, but the failure of crenezumab is another setback for the scientific argument that clearing plaques of toxic proteins called beta-amyloid from the brain can slow or prevent Alzheimer’s disease. (Feuerstein, 6/16)

In other pharma news —

Statistic: FTC Warns Drug Makers and PBMs Against Illegal Reimbursement Programs

In a notable move, the Federal Trade Commission has warned drugmakers and drug benefit managers that the agency will “step up enforcement” of any “illegal kickbacks and rebate programs” that make it harder for patients access to medicines at lower cost. The new policy statement notes that the FTC plans to review miscellaneous rebates and fees for signs that these payments violate antitrust and consumer protection laws. As part of this effort, the agency plans to monitor lawsuits and file its own legal briefs in cases where it can provide assistance in analyzing illegal practices that may increase prescription drug prices. (Silverman, 6/16)

Bloomberg: Walgreens aims to add diversity to in-store drug trials

Walgreens Boots Alliance Inc. is entering a new dimension of healthcare with a company designed to help improve the diversity of drug trials by making them more accessible to patients. Typically conducted in hospitals, doctors’ offices, universities, and research clinics, human trials of experimental drugs and devices often fail to reach a wide variety of ages, races, and ethnicities. Walgreens will begin offering its outlets, which number more than 9,000, and patient connections to help address the longstanding issue. (Rutherford, 6/16)

Bloomberg: Bausch Health puts skincare unit IPO plan on hold

Bausch Health Cos. has suspended plans to IPO its skincare business Solta Medical, a month and a half after the spin-off of another unit failed to meet its fundraising targets. With its own stocks battered this year amid volatility and inflation fears, Bausch Health said in a statement Thursday that it had decided to put its Solta plans on hold “in light of difficult market conditions and other factors”. The company said its stakeholders’ interests are best served in the short term by focusing on driving Solta’s revenue, earnings and cash flow. (Hytha, 6/16)

KHN: Proposal to import drugs from other countries creates unusual alliance in Senate

Harmony is not often found between two of Capitol Hill’s loudest senators, Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.). But he was there when Tuesday’s Senate Health, Education, Labor and Pensions Committee tagged legislation to reauthorize the Food and Drug Administration’s user fee program, which is set to expire. September 30. (Knight, 6/17)

Also –

The Hill: Over 400,000 bottles of over-the-counter drugs recalled due to child safety concerns

The Consumer Product Safety Commission announced on Thursday the recall of more than 400,000 bottles of over-the-counter medicines due to problems with child-resistant packaging, which did not meet the requirements of the Act. poison prevention packaging. Aurohealth has recalled approximately 137,300 units of Walgreens brand acetaminophen, as well as approximately 25,660 units of Kroger brand acetaminophen for arthritis pain. (Scully, 6/16)

This is part of the KHN Morning Briefing, a summary of health policy coverage by major news outlets. Sign up for an email subscription.

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