USA – Roche, Novo Nordisk and Merck Weigh in on FDA Draft Guidance on Assessment of Pressor Effects

Companies took issue with specific elements of the draft guidance advising sponsors on the premarketing assessment of a drug’s effect on blood pressure.

Roche/Genentech explained, “While we agree with the spirit of the draft guidance with respect to ambulatory blood pressure monitoring (ABPM), we believe that a risk-based approach would better address the concern of potential drug-induced effects on blood pressure (BP) by reserving ABPM investigations ‘for cause’ (e.g., based on mechanism or action, high-risk population, or evidence of a blood pressure effect in early emerging data).”

The drugmaker made clear that smaller trials could have difficulties.

“Given the trend in drug development towards smaller, more targeted studies in rare subsets of disease and the challenges associated with recruiting patients for these studies, we note that it may be challenging to power such studies to detect blood pressure effects in the 2 to 3mm Hg range.”…