FDA To Review Gilead’s Ambrisentan And Encysive’s Thelin Back-To-Back
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency granted Gilead’s pulmonary hypertension candidate a priority review, setting a June 18 user fee date that falls days after the review timeline for Thelin.
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Two competing products for the treatment of pulmonary arterial hypertension could hit the market at the same time later this year after FDA granted review timelines for the endothelin receptor antagonists, Gilead's ambrisentan and Encysive's Thelin (sitaxsentan), that fall within three days of one another. Gilead announced FDA had granted a priority review for its NDA for ambrisentan for the once-daily treatment of PAH Feb. 16. The agency set a June 18 user fee date for the application. That review is scheduled just three days after the review timeline set by the agency for Encysive's NDA for Thelin. Encysive announced in December that Thelin has a June 15 user fee date, after FDA accepted the company's response to a July 24 "approvable" letter as a complete response (1 (Also see "Encysive Thelin Approval Could Come Days Ahead Of Gilead’s Ambrisentan" - Pink Sheet, 28 Dec, 2006.)). Encysive had been seeking a Class 1 resubmission, which would have given the application a shorter action timeline, but the agency designated the application a Class 2 resubmission, meaning it would grant review within six months. The company has had several opportunities to gain regulatory clearance for Thelin well ahead of Gilead's entry, but was thwarted by two "approvable" letters. Gilead, meanwhile, submitted its NDA for ambrisentan Dec. 18 based on data from two Phase III trials (2 (Also see "Gilead Submits NDA For Ambrisentan For PAH" - Pink Sheet, 19 Dec, 2006.)). Both companies have begun ramping up for a launch. Encysive has employed 52 sales reps to market the product since recruiting and training them in preparation for the introduction originally anticipated last year. In January, Gilead said it was already preparing to launch ambrisentan and would eventually recruit 75 to 100 sales reps (3 (Also see "Gilead Ramps Up For Ambrisentan; Calls For 75 To 100 Sales Reps" - Pink Sheet, 9 Jan, 2007.)). - Jessica Merrill ([email protected]) |