FDA clears Arena and Eisai’s obesity drug
pharmafile | June 28, 2012 | News story | Sales and Marketing | Arena, Belviq, Eisai, FDA, Qnexa, Roche, obesity
Eisai and Arena’s Belviq has gained FDA approval, making it the first obesity drug to be approved in over ten years.
Belviq (lorcaserin) is now approved for adults who have a body mass index greater than 29, or are overweight but afflicted by high blood pressure, high cholesterol or type II diabetes.
The drug works by activating the serotonin 2C receptor in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food.
Belviq has become the first obesity treatment approved in the US since Roche’s Xenical (orlistat) in 1999. Analysts predict the drug could make $500 million in peak annual sales.
Arena and Eisai have stolen a march of their rival Vivus, whose obesity drug Qnexa is also awaiting an FDA decision, expected on 17 July.
Arena will manufacture and supply the finished commercial product from its facility in Switzerland, whilst Eisai will market and distribute the drug in the US.
As part of the drug’s approval, the companies have been told by the FDA to conduct post-marketing studies to assess the safety and efficacy of Belviq.
The US regulator has turned down a number of obesity drugs in the past because of concerns over their affect on the heart and wants to ensure that Belviq is safe in the long-term.
The post-marketing studies will evaluate the long-term effect of treatment with Belviq on the heart it events in overweight and obese patients with a history of cardiovascular disease or other risk factors.
The approval is based on three clinical studies, which showed that Belviq, along with diet and exercise, was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after one year, and managing the weight loss for up to two years.
“Diet, exercise and behavioural therapy alone may not result in sustained weight loss for many overweight and obese people trying to lose weight,” said Lonnel Coats, president and chief executive officer at Eisai.
“Belviq represents an important therapeutic option for physicians responsible for the medical management of their patients who are overweight or obese.”
According to the US Centers for Disease Control and Prevention, two-thirds of American adults are overweight or obese.
Furthermore, the prevalence of obesity in the US more than doubled among adults from 1980 to 2010, meaning any new – and safe – obesity drugs could be highly lucrative.
Ben Adams
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