If the Sequel results are positive, Vivus could submit the two-year Qnexa data to FDA for review. However, it's not clear if the agency would have time to review the data by the agency's Oct. 28 deadline. If not, FDA could extend the Qnexa review by another three or six months.
Key, upcoming events in the race to develop an approvable obesity drug:
Before end of September:
Top-line results from Vivus' two-year "Sequel" extension study of Qnexa.Oct. 22: FDA approval decision date for Arena Pharmaceuticals' lorcaserin. Oct. 28: FDA approval decision date for Vivus' Qnexa. Dec. 7: FDA advisory panel for Orexigen Therapeutics' Contrave. Before end of 2010: Arena reports results from phase III study of lorcaserin in obese patients with diabetes -- the so-called Bloom-DM study. Jan. 31, 2011: FDA approval decision date for Orexigen's Contrave. --Written by Adam Feuerstein in Boston.
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