Lorcaserin, an investigational obesity drug, was given a positive recommendation by the Endocrinologic and Metabolic Drugs Advisory Committee, which advises the Food and Drug Administration (FDA). The Committee voted 18 to 4 in favor, with one abstention, in advising the FDA whether to approve the medication for obese or overweight individuals. The majority of the members of the Committee found that available evidence shows that lorcaserin’s potential risks are outweighed by its possible benefits.
Lorcaserin is intended for obese and overweight patients for weight management, including weight loss and then maintaining a healthy body weight. An obese individual has a BMI (body mass index) of 30 or more, while that of an overweight person is between 25 and 29.9. Patients should also have one co-morbid condition.
Arena’s President and Chief Executive Officer, Jack Lief, said:
“The advisory committee’s positive vote supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity. We will continue to work with the FDA as the agency completes its review of the lorcaserin new drug application.”
Even though the Committee advices the FDA on drug approvals, its recommendations are not binding and the Agency (FDA) can do what it likes. However, historically, the FDA usually goes along with the recommendations.
The FDA is expected to complete its review of lorcaserin by June 27th, 2012.
Lonnel Coats, President and Chief Executive Officer, Eisai Inc., said:
“Eisai’s commitment to advancing innovative therapies in areas of medical need continues to be a cornerstone of our corporate mission. We look forward to the outcome of the lorcaserin new drug application discussions with the FDA.”
Lorcaserin is an experimental medication aimed at helping overweight/obese people manage their body weight. It is a new chemical entity; scientists believe it functions as a selective serotonin 2C receptor agonist.
The hypothalamus is a brain area believed to be in control of metabolism and appetite – the serotonin 2C receptor is expressed in the brain, including the hypothalamus.
Arena Pharmaceuticals, a clinical-stage biopharmaceutical company, submitted the original NDA (New Drug Application) to the FDA in 2009. The Agency sent a CRL (Complete Response Letter), a year later. It was resubmitted at the end of 2011.
The exclusive rights to sell and distribute lorcaserin in the USA (when/if FDA approved) is held by Eisai Inc.
The European Medicines Agency accepted lorcaserin’s marketing authorization application for filing in March this year.
Arena Pharmaceuticals shares almost doubled in value today, according to the Wall Street Journal – they reached their highest point in 20 months.
Arena does not yet know whether the FDA may ask it to provide post-market studies when/if lorcaserin is approved.
Written by Christian Nordqvist