Drugs

CDER Used AI/ML in Kineret EUA

CDER says it used artificial intelligence/machine learning (AI/ML) in 2022 to identify a suitable patient population for emergency use authorization of Sobi’s Kineret (anakinra), an interleukin-1 inhibitor indicated to treat Covid-19 in hospitalized adults with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor. A CDER post says the lack of an approved test for soluble urokinase plasminogen activator receptor led the review team to use AI/ML to facilitate the identification of patients who could receive the drug under the EUA.

“The goal was to develop a scoring rule that would ensure a high proportion of patients meeting the criteria [from the SAVEMORE trial]…., CDER says. “This was the first time that CDER used AI/ML for a regulatory decision….”

The review team identified eight criteria for the clinical scoring rule, the post says. “The review team combined the predictive ability of AI/ML with appropriate validation processes to develop a method to identify the patient population who will likely benefit from anakinra treatment under this EUA,” the post says. “These findings show that identifying patients using the scoring rule can increase the probability that these patients will experience the benefits seen in the SAVEMORE trial.”

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