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FDA Workshop Will Focus on Development of Antihypertensive Therapies for Use in Pediatric Patients

Treatment of chronic hypertension (high blood pressure) in pediatric patients remains an area of unmet medical need, with limited FDA-approved therapies, particularly for children younger than six years of age. Products are being developed to treat uncontrolled and/or resistant hypertension in adults that may have benefits in pediatric patients.

This FDA public workshop, hosted with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will bring together key stakeholders, including clinicians, academicians, regulators, industry, and patients/caregivers, to discuss the similarities and differences in disease pathophysiology and drug response across age groups, determine the extent to which efficacy can be extrapolated from adults to pediatrics, identify development priorities for both initial therapy and uncontrolled hypertension, and explore feasible strategies to generate evidence for the safe and effective use of antihypertensive treatment(s) in pediatric patients with hypertension, including children younger than six years of age.

Please visit this webpage for more information and to register for the meeting.

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