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US FDA advisors add uncertainty to Pfizer's bid for longer sildenafil exclusivity

This article was originally published in Scrip

Executive Summary

After the 29 July meeting of the US FDA's cardio-renal advisory committee meeting, which discussed a paediatric indication for Pfizer's pulmonary arterial hypertension (PAH) drug Revatio (sildenafil), the company issued a statement saying it was "encouraged" by the deliberations. However, the committee was split by seven votes to six on one key area and decided to not even vote on the question which was of most direct relevance to Pfizer's situation.

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