Drugs

Comments on Presser Assessment Guidance

Amgen says that while it appreciates FDA’s issuance of a draft guidance on the assessment of presser effects of drugs, it has concerns about the agency’s recommendations to use ambulatory blood pressure monitoring for any drug intended for chronic use. The company comment says it is skeptical that such monitoring will be effective for detecting very small differences in blood pressure in clinical trial settings as described in the draft guidance. Amgen urges FDA to instead recommend a risk-based, development program-specific approach to assessing blood pressure effects.

In its comment, GlaxoSmithKline asks FDA to consider how recommendations in the guidance may differ for drugs that are intended for use in patients with existing hypertension and who may be taking multiple antihypertensive medications, or for drugs that may include large cardiovascular trials in the regulatory application. It also says the agency may consider whether an algorithm could be useful to outline the potential decision steps regarding short-term/long-term studies and the relevant definitions.

Novartis asks FDA to consider alternative approaches to detect potential drug-induced effects on blood pressure with high-quality data without the need for a separate dedicated blood pressure study in the target population.

AstraZeneca asks whether FDA plans to hold an open general meeting with the public to discuss the new version of the draft and ask questions. It also asks if the home blood pressure measurement device study can substitute for an ambulatory blood pressure monitoring study.

All four companies provided line-by-line specific comments, as did Bristol-Myers Squibb, and Bayer.

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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