Drugs

Risk-Based Approach to Therapeutic Protein DDI

A new FDA guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins, lays out a risk-based approach to determining when drug-drug interaction (DDI) studies are needed for therapeutic proteins. In a Guidance Recap Podcast, CDER Office of Clinical Pharmacology policy lead Qin Sun says that several aspects should be considered when evaluating DDI risks for therapeutic proteins, including DDI mechanisms, disease type and severity if the DDI mechanism is related to the disease condition, product type, clearance pathways, and co-administered drugs in targeted patient populations.

“The guidance also includes a decision tree that summarizes the main concepts of the risk-based approach for different DDI scenarios,” he says.

Sun emphasizes that DDI mechanisms for therapeutic proteins are very different compared to small molecules, and could also be unique to individual protein products. “It is important to know when and how to evaluate these DDI risks for different scenarios. Also, for pro-inflammatory cytokine modulators, there are multiple options to address the DDI risks, and it is possible to provide labeling language or justification without clinical DDI studies for those therapeutic proteins.”

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

Read more

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