Sunday, October 23rd, 2011 at
6:41 pm
Arena Pharmaceuticals, Inc. and Eisai Inc. announced late September 2011 that new data analyses from the lorcaserin Phase 3 clinical trial program will be presented in poster sessions at Obesity 2011, the 29th Annual Scientific Meeting of The Obesity Society in Orlando, Florida.
Arena submitted a New Drug Application (NDA) for lorcaserin to the FDA in December 2009, and the FDA issued a Complete Response Letter (CRL) in October 2010.
Arena’s wholly owned subsidiary, Arena Pharmaceuticals GmbH, has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States subject to FDA approval of the lorcaserin NDA.
Lorcaserin is an investigational drug candidate intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (BMI >/= 30) or patients who are overweight (BMI >/= 27) and have at least one weight-related co-morbid condition. Lorcaserin is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism.
Friday, July 16th, 2010 at
4:44 pm
The FDA panel Voted against the Obesity Drug Qnexa yesterday.
The advisory committee voted 10 to 6 against endorsing the weight loss drug Qnexa, signaling heightened concerns for possible health risks associated with a new generation of diet pills.
The F.D.A. is scheduled to decide by late October whether to approve Qnexa. It usually abides by the advice of its advisory committees.
The outcome of the advisory committee meeting on Qnexa could also mean a more difficult time for two other new weight loss drugs that will face advisory committee hearings this year. These are Lorcaserin from Arena Pharmaceuticals and Contrave from Orexigen Therapeutics.
We keep you posted here.
Thursday, July 15th, 2010 at
9:40 pm
A new report support that Arena Pharmaceuticals Inc.’s lorcaserin prompted weight loss without heart-related side effects.
The study showed that lorcaserin caused more people to lose at least 5 percent of their body weight over one year, or more than double the rate of placebo. The results will be in Thursday’s New England Journal of Medicine.
Lorcaserin weight loss drug is one of three potential obesity drug blockbusters that could reach the market over the next several years.
Qnexa weight loss drug receives FDA approval this week (see previous post).
Contrave, the third weight loss drug is up for FDA review in December.