Arena Pharmaceuticals Inc. (NASDAQ: ARNA) saw its shares jump in Monday’s session on news of an U.S. Food and Drug Administration (FDA) approval. The company announced that the FDA has accepted for filing the New Drug Application (NDA) for an extended release formulation of lorcaserin. If this is approved, the extended release formulation will offer patients a chronic weight management treatment in a once-daily dosing option.
Lorcaserin is currently approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who are obese, or just overweight with at least one weight-related medical condition, such as high blood pressure, high cholesterol or type 2 diabetes. This is believed to decrease food consumption and promote satiety by selectively activating the serotonin 2C receptors in the brain.
The extended release formulation of lorcaserin is investigational and not approved by any regulatory agency.
At the moment it is not known if Belviq is safe and effective when taken with other prescription, over-the-counter or herbal weight loss products, nor is it known if Belviq changes the risk of heart problems or stroke, or death due to heart problems or stroke.
Craig M. Audet, Ph.D., Arena’s Senior Vice President of Operations & Head of Global Regulatory Affairs, said:
The filing of this application by the FDA means they have made a threshold determination that it is sufficiently complete to permit a substantive review. This extended release formulation has the potential to offer patients once-daily dosing of lorcaserin, which can be an important addition to their chronic weight management plan.
Frank Ciriello, President, Eisai Global Neurology Business Unit and Established Products, added:
The dramatic rise in obesity has major consequences for public health. If approved, this once-a-day option will provide another choice for appropriate patients who find it difficult to lose weight through diet and exercise alone.
Shares of Arena were trading up about 9% at $2.35 on Monday, with a consensus analyst price target of $5.50 and a 52-week trading range of $1.60 to $6.28.
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