Drugs

Alzheimer’s Researchers Want Revised Drug Approval Standard

Alzheimer’s disease researchers have published an analysis, “Single Endpoint for New Drug Approvals for Alzheimer's Disease,” that urges FDA to clarify and modernize its current approach for approving new treatments for Alzheimer’s. The analysis recommends that FDA approve new medicines that demonstrate a proven benefit on at least one therapeutic endpoint — either cognition or function. “The current FDA standards require a new drug to show benefits on both proven endpoints, an unnecessarily challenging hurdle the authors say may be inhibiting investment in new Alzheimer’s treatments,” the researchers say. The authors are members of ResearchersAgainstAlzheimer’s (RA2).

“If the FDA were to state that meaningful efficacy on a single endpoint is sufficient for approval, we believe that it would impact prospective investments in this therapeutic area as well as clinical-trial design,” write the authors. “We believe a clarified and modernized FDA approval standard for Alzheimer’s disease would catalyze renewed investment in the discovery and development of new medical advances for Alzheimer’s disease, particularly in early-stage companies and for venture investment.” Specifically, the authors argue, “if a new drug improves memory but has less positive impact on a patient’s daily functioning skills, the medication should still meet standards for FDA approval, because clinically meaningful improvements in cognition matter importantly to persons with Alzheimer's independent of functional improvement and vice-versa.”

The analysis notes that Alzheimer’s disease biopharmaceutical research is lagging well behind other diseases, despite the fact that Alzheimer’s diagnoses will triple in future decades and that there is no current means to prevent, treat or cure the disease. It adds that in 2014-2015, there were only 135 ongoing interventional Alzheimer’s disease clinical trials compared to nearly 5,000 similar trials for oncology drugs.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome