Last week, the US Food and Drug Administration approved a pill to treat overweight or obese adults. The last time this happened was in 1999.
When combined with a healthy diet and exercise, Belviq (lorcaserin) can help people lose about 3–4% of their body weight. Doesn’t exactly sound like a miracle drug, but it does suppress food cravings by mimicking the effects of serotonin in the brain, making people eat less and feel full.
The drug, developed by Arena Pharmaceuticals in San Diego, is approved for use by obese people with a body mass index (BMI) greater than 30, and for a subset of overweight people (with a BMI of more than 27) who have at least one weight-related condition such as high blood pressure, elevated cholesterol, or type 2 diabetes.
More than one-third of adults in the US are obese, costing the economy an estimated $147 billion a year in medical expenses and lost productivity. But the field of obesity drugs had been effectively dead. A little obesity drug history from Nature News:
- In 1997, the weight-loss drug fenfluramine was pulled from the market for causing heart-valve problems.
- Orlistat (Roche’s Xenical and GlaxoSmithKline’s Alli) was approved in 1999 and blocks the uptake of fat calories.
- In the past 2 years, the FDA has rejected a total of 3 obesity drugs because of concerns over safety or lack of efficacy.
- The FDA rejected Arena’s first application for approval of Belviq in 2010 because the compound seemed to produce tumors in rats and because the company could not statistically rule out an increase in the risk of heart-valve problems.
- That year also saw the rejection of Vivus' Qnexa, and the rejection of Contrave from Orexigen Therapeutics and Takeda Pharmaceutical came in early 2011.
The FDA’s turnaround last week arrived after Arena performed echocardiograms in nearly 8,000 people to measure heart-valve function, revealing no increase in heart-valve abnormalities among those taking the drug. But regardless, patients with congestive heart failure are advised not to take the drug.
- A 200-pound patient on Belviq loses, on average, an extra 6 or so after a year.
- About 20% of people on the drug lost 10% or more of their body weight. Patients who haven’t lost 5% of body weight by week 12 should probably stop taking the drug.
- Belviq has also shown promise for people with type 2 diabetes, who were twice as likely to keep their blood sugars under control than those on the placebo.
Arena has licensed the medicine to Tokyo-based Eisai to sell in the US. The Japanese drugmaker jumped 4% after the approval, the biggest surge in 2 years, Bloomberg Businessweek reports. Arena increased 29%.
The medicine may reach sales of about $2 billion in 2020. The firm has agreed to run 6 post-marketing studies, including a long-term cardiovascular trial.
The drug won’t be available until after the Drug Enforcement Administration (DEA) reviews the recommendation; this normally takes from 4 to 6 months, so the drug might not be available until next year.
You can read the FDA announcement here.
Image: new drug application review / FDA history