FDA Approves Arena's Lorcaserin
On Wednesday, the much awaited FDA decision on Arena Pharmaceutical's (NASDAQ: ARNA) obesity drug was released. The FDA approved the drug known as Lorcaserin, which will be sold under the brand name Belviq. Arena shares spiked upward after the news.
The drug marks a new stage in the war on obesity, as health care advocates are trying to find new ways to fight this epidemic. Initially, the drug did not pass FDA inspection. However, further research and testing has given the FDA confidence that the drug is safe enough to release to the mass market.
The drug is one of three obesity drugs that has been seeking FDA approval, the other two being made by Vivus (NASDAQ: VVUS) and Orexigen Therapeutics (NASDAQ: OREX). Arena's new pill is approved for adults who are obese (those who have a body mass index, known as the BMI, over 30) or who are overweight (BMI over 27) and have at least one other weight-related medical condition such as type 2 diabetes or high blood pressure.
Arena will be required to monitor the drug and must run six more studies to ensure the safety of the drug. One of these studies will study heart safety, as there are concerns that obesity drugs cause heart damage. The FDA is also concerned with clotting and the risk of strokes in users. Arena's Belviq is the first obesity drug to be approved in 13 years by the FDA, largely due to these fears.
Shares of Arena traded higher by more than 35% after the announcement. Biopharmaceutical companies Vivus and Orexigen also saw significant share price action. Vivus shares climbed more than 8% and Orexigen shares climbed 30% higher following the news. Both companies still plan on bringing their own obesity drugs to market if they receive FDA approval.
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