Memorandum

FDA approves Orexigen/Takeda’s Contrave for weight management – September 10, 2014

Earlier this evening, the FDA approved Orexigen/Takeda’s Contrave (naltrexone/bupropion) for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a BMI >30 or those with a BMI >27 and at least one weight-related condition (the same indication as Vivus’ Qsymia and Arena/Eisai’s Belviq). This marks three obesity pharmacotherapies approved by the FDA in the last two years, and one waiting in the wings with Thursday's Advisory Committee for Novo Nordisk's liraglutide 3.0 mg. Similar to the stopping rules for Qsymia and Belviq, Contrave should be discontinued after 12 weeks if a patient has not lost at least 5% of baseline body weight. The FDA is requiring the following post-marketing requirements: a cardiovascular outcomes trial to assess the cardiovascular risk associated with Contrave use (we assume this means continuing the LIGHT study, from which interim results supported approval); two pediatric studies; three other clinical studies (cardiac conduction, hepatic/renal impairment, drug-drug interactions), and one nonclinical study. The approval comes one day ahead of the extended PDUFA date and on the eve of tomorrow’s FDA advisory committee for Novo Nordisk’s liraglutide 3.0 mg for obesity (see our preview). As noted in our Orexigen 2Q14 report from August, Takeda (Orexigen’s North America commercialization partner for Contrave) has prepared a plan to launch the drug this fall. We will hear more on Orexigen’s call tomorrow morning at 8:30 am EST (Melissa will be listening from the FDA hallway, on a break from lira) and be back with additional details.