Drugmakers Call for More Details in FDA Guidance on Assessing Pressor Effects
FDA draft guidance on assessing a new drug’s impact on blood pressure does not adequately explain the agency’s thinking on the use of smaller clinical trials and should incorporate a more risk-based approach, according to comments from three leading drug sponsors.
Roche noted the logistical difficulties of smaller trials and said it would be hard to design such studies to detect blood pressure effects in the 2 to 3mm Hg range.
Roche also called for a more risk-based approach to potential drug-induced effects on blood pressure and said ambulatory blood pressure monitoring (ABPM) investigations should be reserved “for cause,” that is, “based on mechanism of action, high-risk population or evidence of a blood pressure effect in early emerging data.”
Merck noted that, in trial populations, there are circumstances where assessing pressor effects in the target disease population could be logistically difficult and performing the assessment in a population “akin to” the target population may be more appropriate. It suggested the final guidance should allow sponsors to consider a patient population similar to the intended target population.
Novo Nordisk called on the agency to provide more detail on the use of home blood pressure measurements as an alternative to ABPM, noting the ambulatory approach can present logistical challenges due to the required data analysis and equipment involved.