Drugs

Companies Answer FDA PPI Questions

Four drug companies have submitted their answers to an FDA docket seeking input to assist with development of a policy or guidance document on assessment of pH-dependent absorption and potential drug-drug interactions (DDI) with pH modulating agents such as proton-pump inhibitors (PPIs) or acid reducing agents (ARAs). Novartis says the purpose of a PPI DDI study is typically to investigate the effect of multiple doses of a proton pump inhibitor such as omeprazole or rabeprazole on the pharmacokinetics of a single oral dose of drug X in tablet formulation in healthy subjects. It notes that in some disease areas such as oncology, the majority of patients frequently take acid-reducing agents, thus raising the potential for drug interactions between oral weakly basic anti-cancer agents and acid reducing agents.

AstraZeneca says there is not a simple translation between physicochemical properties of a drug substance, the dose, the drug product, and the clinical impact of pH-dependent drug-drug interactions and thus a case-by-case approach is appropriate. It proposes that the decision-making and guidance should be based on a totality of data foundation and a growing knowledge of in-vitro in-vivo correlations that includes physicochemical properties of the drug candidate, dissolution formulation properties, nonclinical pharmacology, principles of PBPK (physiologically based pharmacokinetics), clinical pharmacology, and clinical trial data.

Comment letters submitted by AbbVie and Takeda answer specific questions posed by FDA in the docket.

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