Drugs

Use Surrogate Endpoints More Selectively: Researchers

Researchers in the UK and Italy say there should be more selective use of surrogate endpoints when evaluating new drugs so that they are restricted to use in chronic diseases, especially when collecting data on patient-relevant clinical outcomes requires trials with unattainably long follow-up. Writing in thebmj, the researchers say that while using surrogate endpoints to measure whether a new drug works can reduce the duration, cost, and complexity of clinical trials before regulatory assessment and facilitate faster patient access to new therapies, especially for chronic diseases, they make it challenging for health technology assessment bodies to make decisions.

“Regulators should be more selective in their use of surrogate endpoints,” the article concludes. “Surrogate endpoints should not be used when a drug’s effect on the final clinical outcome can be observed within a relatively short time frame, as in acute conditions. Hence, their use should be reserved for chronic conditions when they can provide early and accurate measurement of a drug’s effect, especially when long follow-up is required before patient-relevant clinical outcomes can be assessed. Even in such cases, regulators can use other tools to ensure patients who have exhausted all available treatment options can receive investigational treatments before regulatory approval.”

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