ARTICLE | Clinical News

Mysimba naltrexone SR/bupropion SR regulatory update

December 22, 2014 8:00 AM UTC

EMA’s CHMP recommended approval of Mysimba naltrexone/bupropion from Orexigen in combination with diet and exercise for weight management in adult patients with a BMI of =30 kg/m 2 or a BMI of =27 to <30 kg/m 2 with =1 weight-related co-morbidities. CHMP said patients given Mysimba should be evaluated after 16 weeks of treatment and treatment should be stopped if the patient has not lost =5% of their initial body weight. ...