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Panel narrowly backs use of PVRI for pediatric PAH

July 29, 2010 11:58 PM UTC

An FDA panel voted 7-6 on Thursday that pulmonary vascular resistance index (PVRI) could be used to demonstrate effectiveness and derive dosing information in pediatric trials of pulmonary arterial hypertension (PAH) drugs that already are approved in adults. The Cardiovascular and Renal Drugs Advisory Committee did not vote on a separate question of whether Pfizer Inc. (NYSE:PFE) could use available hemodynamics data in children to support pediatric approval of PAH drug Revatio sildenafil. An FDA spokesperson said the panel did not have enough information to vote on the topic. ...