FDA posts Revatio briefing documents

FDA asserted that pulmonary vascular resistance index (PVRI) should be used as a surrogate endpoint in the pediatric development of products to treat pulmonary arterial hypertension (PAH). The comments came in briefing documents ahead of Thursday's Cardiovascular and Renal Drugs Advisory Committee meeting to discuss use of the hemodynamic marker in the pediatric development of PAH drug Revatio sildenafil from Pfizer Inc. (NYSE:PFE), which is already approved in adults. Revatio has completed a Phase III trial in children with PAH.

The documents noted that in 13 PAH trials, there was a significant relationship observed between PVRI and the usual measurement of treatment effectiveness, the change in six-minute walk distance (6MWD). FDA said that children, especially those under seven, cannot perform a reliable 6MWD test. ...