Close on the heels of the US approval of its weight loss drug lorcaserin HCl (US trade name: Belviq), Arena Pharmaceuticals, Inc. filed a Marketing Authorization Application (MAA) seeking to get the drug approved in Switzerland.
Arena Pharma is looking to get lorcaserin approved as an adjunct to diet and exercise for weight control in obese (Body Mass Index, or BMI, >30) or overweight (BMI >27) patients suffering from at least one weight-related co-morbid condition. Arena Pharma’s marketing application is expected to be accepted by the Swiss agency for Therapeutic Products (Swissmedic) later this month.
Arena Pharma is seeking approval for lorcaserin in Switzerland on the basis of data from three double-blind, randomized, placebo-controlled studies. Results from the studies revealed that treatment with lorcaserin in combination with diet and exercise was more effective than only diet and exercise in helping patients to lose 5% or more of their weight after one year and managing the weight loss for up to two years.
We note that apart from being approved in the US, lorcaserin is under review in the EU. Approval in the EU and Switzerland would boost the sales potential of the drug.
Currently, we have a long-term Neutral recommendation on Arena Pharma. The stock carries a Zacks #2 Rank (Buy rating) in the short run. We believe that the US approval of lorcaserin is responsible for the positive short-term stance. We are also positive on the company’s efforts to get the drug approved in additional markets. Other companies that are working on gaining approval for their obesity candidates include Orexigen Therapeutics, Inc. and Vivus Inc. . The US Food and Drug Administration is expected to decide on Vivus’ obesity candidate Qnexa shortly (target date: July 17).