September 10, 2020 — Back in February we complained about “a near complete failure of transparency in drug safety decision making” by FDA. Our complaint had to do with taking lorcaserin (Belviq) off the market. Today, FDA took a step toward a bit more transparency. In the New England Journal of Medicine, senior FDA officials explained their thinking about […]
February 14, 2020 — FDA yesterday requested that Eisai withdraw lorcaserin (Belviq®) from the market due to a small increase in cancer observed in a large cardiovascular safety study. Eisai disagreed with the request but complied with the request nonetheless. We have no data to help us understand what is going on. Is FDA over-reacting to a spurious observation? […]
March 23, 2019 — It’s great to have new options for obesity meds. Since 2010, FDA has approved four of them. But the fact is that the mainstay of obesity meds is still something that’s older than dirt – phentermine. And new data suggests that it can work safely and effectively when used as a chronic med for this […]
October 9, 2018 — Tuesday is obesity medicine day for National Obesity Care Week. And it just so happens that we have two new studies on the subject in the Lancet. They point to a trend. Day by day, we see evidence of more options and better outcomes for medical obesity care. A New Dual-Receptor Agonist Juan Frias and […]
August 27, 2018 — Back in July, we told you about a landmark cardiovascular outcomes study with lorcaserin. We only had topline results at that point, but we knew that this would be big. Today, we have a publication in the New England Journal of Medicine, an editorial, and lots of hyperbolic buzz in headlines all over the world. […]
July 18, 2018 — For the first time ever, we have direct evidence for the long-term cardiovascular safety of an obesity medication. The drug is Belviq, also known as lorcaserin. Yesterday, Eisai released topline results for the long-awaited CAMILLIA-TIMI 61 trial. This was a five-year cardiovascular outcomes study of 12,000 patients. It was randomized and placebo controlled. CV Safety […]
March 13, 2018 — It’s a tale of two obesity drug makers. One – Orexigen – filed for Chapter 11 bankruptcy yesterday. Orexigen markets Contrave, a combination drug made from bupropion and naltrexone. The other company – Novo Nordisk – is building upon the early success of its obesity drug, Saxenda (liraglutide 3mg). Why are the fortunes of these two companies so […]
August 22, 2017 — Among the complex web of factors that are causing obesity to rise, you will find the rise of drugs that cause weight gain. New antipsychotic drugs – like olanzapine or Zyprexa – are classic examples. They offer important benefits for people living with schizophrenia or bipolar disease. But they have a downside. They can cause obesity and metabolic […]
June 25, 2017 — This past week saw three bits of steady progress on the new generation of obesity drugs: lorcaserin, liraglutide, and semaglutide. It’s all movement in the right direction. Lorcaserin Cardiovascular Outcomes Study Progressing Nicely A huge cardiovascular outcomes study is underway with 12,000 patients receiving either lorcaserin (Belviq) or a placebo. The goal is to learn […]
July 21, 2016 — Eisai and Arena Pharmaceuticals announced this week that they received final approval from FDA for once-daily lorcaserin, which will be sold as Belviq XR for long-term obesity treatment. The real question is: what will this mean for the product, the patients who can benefit from it, and for obesity care more broadly? This approval will […]
