Memorandum

European Commission approves Orexigen’s Mysimba (naltrexone/bupropion) for obesity – April 2, 2015

Executive Highlights

  • Orexigen announced last week that the European Commission has granted marketing authorization for its obesity drug Mysimba (naltrexone/bupropion; known as Contrave and partnered with Takeda in the US), making it the second obesity drug approved in Europe in one week.
  • The press release noted that an interim analysis (of 94 MACE) from the Light Study (Mysimba’s CVOT) has been submitted to the EMA for evaluation.

Orexigen announced last week that the European Commission has granted marketing authorization for its obesity drug Mysimba (naltrexone/bupropion; known as Contrave and partnered with Takeda in the US) in all 28 EU member states. Specifically, the drug is approved as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a BMI ≥30 kg/m2 or with a BMI ≥27 kg/m2 and one or more weight-related comorbidities (e.g., type 2 diabetes, dyslipidemia, or controlled hypertension). The press release noted that an interim analysis (of 94 MACE) from the Light Study (Mysimba’s CVOT) has been submitted to the EMA for evaluation – as a reminder, the disclosure of interim data from this trial has been the subject of much recent controversy in the US. As background, Mysimba received a positive CHMP opinion in December, which we later learned was based on an overwhelmingly positive vote of 31-2. This news closely follows the European approval of Novo Nordisk’s Saxenda (liraglutide 3.0 mg) from last Monday, which notably included prediabetes as an example of a comorbidity in its label – for more on Saxenda, see our coverage of last week’s investor call on the drug’s imminent US launch. These past few months have seen a dramatic shift in the previously harsh regulatory environment in Europe surrounding obesity pharmacotherapies: Saxenda and Mysimba are the first obesity drugs to be approved since orlistat in 1998. As Orexigen pointed out, obesity is indeed becoming a worsening epidemic in Europe (accounting for 6% of Europe’s healthcare expenditures, according to Orexigen) and we are thus excited to see more treatment options available for this patient population. We assume this is good news for the future EU resubmission of Vivus’ Qsiva (phentermine/topiramate; known as Qsymia in the US) and Arena/Eisai’s Belviq; we are also curious to see how this reverse sequence of launches in Europe compared to the US will affect the drugs’ performance in the respective markets.

-- by Melissa An, Emily Regier, and Kelly Close