Eisai has received US marketing rights to the weight loss drug Belviq (lorcaserin) from its development partner Arena Pharmaceuticals, and will now be responsible for commercialisation of the drug in the country.
Belviq was approved by the Food and Drug Administration (FDA) in June, 2012, as the first new drug available to treat obesity in the US in 13 years, with Arena the company to initially submit its New Drug Application (NDA).
Eisai will now take over all pharmacovigilance requirements related to the drug, which includes a comprehensive post-marketing surveillance commitment to study Belviq’s long-term safety.
In addition, Eisai plans to submit marketing authorisation applications based on the US NDA to health authorities throughout the Americas for which it currently holds commercialisation rights, including Mexico, Brazil and Canada.
The drug is approved in the US for adults who are classified as obese or overweight with at least one medical complication such as diabetes or high cholesterol.
It works through activating the 5-HT2C brain, leading to patients feeling fuller on a smaller amount of food, and is to be used in conjunction with a reduced calorie diet and increased exercise.
Further competition in the US is expected soon, with Vivus announcing it is planning to launch its rival weight-loss treatment Qsymia (formerly known as Qnexa) during the fourth quarter of 2012 following approval from the FDA.