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The Food and Drug Administration on Thursday fully approved the Alzheimer’s drug Leqembi, amid concerns about its safety, cost and accessibility. The move marks the first time that a drug meant to slow the progression of the disease has been granted full regulatory approval. Other approved drugs only target its symptoms. "I don't think we can understate the significance of this moment," said Donna Wilcock, the assistant dean of biomedicine at the University of Kentucky. About 6.7 million adults ages 65 and older in the United States have Alzheimer’s disease, according to the Alzheimer’s Association. Leqembi, from Japanese drugmaker Eisai...

A recent phase three study conducted by Eli Lilly examined the safety and efficacy of the study drug donanemab in participants with early Alzheimer's disease (AD). The pharmaceutical company Eli Lilly announced in a press release on May 3, 2023, that a clinical trial of the experimental Alzheimer's drug, donanemab, showed it could significantly slow the progress of cognitive decline, allowing patients increased independence. The drugmaker's announcement revealed that the drug succeeded in halting early AD progression in nearly half of the participants, slowing cognitive decline rates by 35% compared to control participants. Donanemab is an antibody that targets protein...

In a critical boost to President Joe Biden's reelection prospects, the Food and Drug Administration has approved a new Alzheimer's drug that "may modestly slow the pace of cognitive decline," according to the New York Times. Biden, the first octogenarian president in American history, is expected to formally announce his plans to seek a second term sometime next month, thus setting the stage for a potential rematch against Donald Trump. The president is going to need all the help he can get to mitigate the rapid deterioration of his brain before Election Day in 2024, which is probably why his...

The U.S. Food and Drug Administration (FDA) had asked for a federal investigation into its approval of a controversial Alzheimer's drug. Dr Janet Woodcock, acting commissioner of the FDA, announced she sent a letter to the Office of Inspector General of the U.S. Department of Health & Human Services for a probe into communications between FDA staff and Biogen Inc representatives in the lead up to the approval of Aduhelm, the company's Alzheimer's drug. 'Given the ongoing interest and questions, today I requested that [The Office of the Inspector General] conduct an independent review and assessment of interactions between representatives...

The FDA has just approved a new treatment for early Alzheimer's that's being billed as the first potential "cure" that addresses the root cause rather than just treats symptoms. The drug, aducanumab, could provide hope to millions of patients and families impacted by the terrible disorder. However, there are numerous controversies surrounding the medicine and its approval. First and foremost, not one of the FDA's advisers recommended approving it.

A U.S. drug company did not openly share or perform further studies on a successful rheumatoid arthritis medicine that internal researchers suggested was reducing the risk of Alzheimer's disease by 64 percent, according to Washington Post article published Tuesday. Researchers at Pfizer reportedly urged the firm to conduct a clinical trial after finding the potential hidden benefit of the anti-inflammatory drug Enbrel while analyzing insurance claims. It was estimated to cost $80 million to conduct the trial, and Pfizer decided to pass. Pfizer told the Post it did not pursue the clinical trial because its success rate would likely be...

An experimental Eli Lilly & Co. drug failed to significantly help Alzheimer’s disease patients in a closely watched clinical trial, dealing another blow to the pharmaceutical industry’s long quest to find a better treatment for the condition. The disappointing outcome also may revive doubts about an entire branch of Alzheimer’s research that has dominated the industry’s efforts in the past decade. Lilly and other companies have developed drugs that try to stop the buildup of a sticky protein in the brain known as beta amyloid—believed by many to be the primary culprit in the disease. But none of these drugs...

Sarasota scientists have made a discovery that may pave the way for more effective drug therapies to treat Alzheimer’s patients in the future. In a study published in the Journal of Biological Chemistry, the Roskamp Institute’s scientists say they have isolated a single enzyme connected to all three key factors in Alzheimer’s disease – accumulation of amyloid protein, inflammation and modulation of the “tau” protein. All three damage nerve cells in the brain. “These studies suggest there is a single drug target to inhibit all three key pathologies of Alzheimer’s disease,” stated the study’s lead researcher, neurobiologist Daniel Paris, in...