March 28, 2015 — As expected, Mysimba (naltrexone/bupropion, known as Contrave in the U.S.) became the second new obesity medicine to be fully approved for sale in Europe this week. This week broke a nine-year drought for new obesity medicines in Europe. Now analysts are busy trying to figure out who will be the winners in obesity treatment. Such […]
March 24, 2015 — The European Commission granted final approval late yesterday for Novo Nordisk’s Saxenda brand of liraglutide 3mg to treat obesity. Saxenda is the first obesity treatment in nearly a decade to receive approval in Europe. Novo Nordisk is already in the final stages of preparing to launch Saxenda in the U.S., where it was approved late last […]
March 12, 2015 — Dangerous crosscurrents remain in the regulatory environment for obesity medicines, even though progress has been considerable over the last five years. You need look no further than headlines of the last week. In just one news cycle Orexigen — the originators of Contrave — made both good and bad news for themselves when they disclosed […]
January 24, 2015 — Let’s just say it. European regulators were spooked by obesity drugs for quite a few years. So news that first buproprion/naltrexone (Contrave U.S./Mysimba EU) and now liraglutide (Saxenda) have been recommended for approval in Europe is good news indeed. What spooked the Europeans was the experience with rimonobant. The European Commission (EC) granted Sanofi approval for this obesity treatment in 2006, […]
September 11, 2014 — Late yesterday, Contrave became the third new obesity treatment to be approved by FDA in the last two years. All three of these drugs went through FDA advisory committee hearings in 2010. At the time, Contrave was the only one of the three that the expert panels recommended for approval. Yet in 2011, FDA ruled that […]
September 10, 2014 — FDA (the U.S. Food and Drug Administration, not Fuji Dream Airlines) has set two big milestones for this week in obesity. They both fall on Thursday. Though the real Obesity Week is not until November 2, FDA is creating its own version this week. The first is a bit of old business that is really […]
June 11, 2014 — Orexigen and the rest of the world have been poised for action by the FDA today to approve the drug formerly known as Contrave, a combination of bupropion and naltrexone, for the treatment of obesity. Today, June 11, was the date that FDA was required to render judgement on their resubmitted application, based upon new […]
January 24, 2014 — At the JPMorgan Healthcare Conference, Orexigen presented a good overview of the problem of scale in obesity treatment — the scale of the disease and the scale of the challenge to overcome inertia in treating it. Oh, and they provided helpful perspective on how they plan, with their partners at Takeda, to overcome that inertia. […]
November 25, 2013 — Orexigen announced today that good cardiovascular safety results for Contrave in the ongoing Light Study of cardiovascular outcomes will enable them to resubmit their product to FDA within a few weeks for approval as early as June, 2014. Contrave is a product for treating obesity that combines two older drugs — naltrexone and buproprion — in […]
July 9, 2013 — Most observers of obesity drugs seem to be stuck between visions of boom or bust, with no tolerance for the reality that most likely lies between those two extremes. Obesity medicine physicians need more tools for treating obesity. But because obesity is a complex disease we barely understand, the notion of a breakthrough treatment is […]
