Photo: Flickr / procsilas
The FDA has approved Arena Pharmaceuticals’ new weight-loss drug on Wednesday.Arena’s stock (Nasdaq: ARNA) is up 45 per cent since reopening.
This marked the first time a weight-loss drug has been cleared by regulators in 13 years.
The drug is called Belviq (Locaserin), and the panel voted 18-4 in support of the drug.
The pill won’t let you eat pizza and ice cream with reckless abandon. It works by influencing your brain and making you not want to eat more.
“The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition,” said Janet Woodcock, director of the centre for Drug Evaluation and Research for the FDA.
“If approved by the FDA, lorcaserin will provide an additional tool to fill the gap between lifestyle intervention alone at one end and bariatric surgical intervention at the other end,” said Dr. Robert Kushner, past president of The Obesity Society.
7800 people were tested in 3 different studies.
- Lorcaserin (the actual drug chemical) activates the serotonin 2C receptor, which decreases food intake by increasing feelings of fullness and reducing hunger.
- After one year of treatment, 38 per cent of patients lost at least 5 per cent of body weight, in comparison just 16 per cent lost this amount using a placebo.
- Adverse effects (ranked by prevalence) include headache, backache, sinus inflammation, and nausea.
Some other key points to know about the business of the drug…
- Arena will market and distribute Belviq with Japanese drug maker Eisai, which has exclusive marketing and distribution rights in the United States and most of the rest of North and South America.
- 6 post marketing studies will be required, including a test of long term cardiovascular safety.