For the first time in 13 years, the Food and Drug Administration has approved a new drug to help people lose weight. The FDA gave the green light to Arena Pharmaceuticals to sell Belviq, or lorcaserin generically, a twice-a-day pill that suppresses appetite and appears to affect metabolism by influencing levels of the brain chemical serotonin.
In a press release, BELVIQ (pronounced BEL-VEEK) is an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
“The FDA approval of BELVIQ is an important development for patients who struggle with obesity or are overweight with comorbidities and need help with chronic weight management beyond diet and exercise,” said Jack Lief, Arena’s President and Chief Executive Officer. “We thank our entire team and the patients who participated in our clinical trial program for making this achievement possible.”
“Diet, exercise and behavioral therapy alone may not result in sustained weight loss for many overweight and obese people trying to lose weight,” said Lonnel Coats, President and Chief Executive Officer, Eisai Inc. “BELVIQ represents an important therapeutic option for physicians responsible for the medical management of their patients who are overweight or obese.”
As with any drug there are side effects and precautions: don’t take while pregnant or nursing, may cause Valvular Heart Disease, Changes in Attention or Memory, Mental Problems, Low Blood Sugar (Hypoglycemia), Painful Erections (Priapism) lasting 4 hours or more, Slow Heartbeat and more.
In studies sponsored by Arena, about half of patients taking Belviq lost about 5 percent of their body weight after a year. The most common side effects include headache, dizziness, fatigue, nausea, dry mouth, and constipation.
The FDA had rejected the drug in 2010 after a panel of experts advised the agency to give it a thumbs down because of safety concerns. Early studies indicated the drug might cause tumors in rats and possibly heart problems in people. Lorcaserin works the same way as one part of the fen-phen diet pill combination that was pulled from the market in 1997 because it caused heart valve damage.
But the company submitted new data aimed at alleviating those concerns, and the same panel endorsed approval in May. Some panel members, however, again expressed concerns about the drug’s safety, especially the heart problems, as have some consumer advocates.
“Faced with this serious concern, it would be dangerous and unconscionable for you to allow the FDA to disregard the available evidence and subject large numbers of obese patients, already at risk for cardiovascular disease, to the added risk of damaged heart valves,” wrote Sidney M. Wolfe of the Public Citizen Health Research Group, in a letter to FDA Commissioner Margaret A. Hamburg.
Arena will be required to conduct six additional studies to monitor the drug’s safety, including one specifically designed to examine cardiovascular risks, the FDA said.
The company told Shots it doesn’t yet know the price for Belviq or when it will be available in pharmacies.
Late Wednesday, Arena CEO Jack Lief said on CNBC that Belviq would cost about the same as a Starbucks venti latte in New York. TheStreet.com reported the drug is expected to be available in pharmacies in four to six months.