Companies manufacturing weight loss or diet pills have a hard time getting FDA approval because of their lack of effectiveness and unwatned side effects
A new diet pill was presented to the FDA for approval, but the FDA is questioning it’s effectiveness and it’s possible high risk of cancer.
Arena Pharmaceuticals Inc.’s obesity drug lorcasserin was voted 9 to 5 against approval back in September by the FDA, so the rejection on Friday was no surprise.
It is disappointing in the efforts to help stop obesity. With about one third of the American adult population being obese and another one third over weight, they consider this one of the nations biggest medical problems. With weight problems come health issues like high blood pressure and diabetes, just to name a few.
Arena’s president and chief executive Jack Lief said, “We intend to meet with the FDA to obtain further clarity on the approval path and time line. We will work with the agency to address the issues with our [new drug application] as quickly as possible.”
The San Diego company is racing with 2 other companies, Orexigen Therapeutics Inc. and Vivus Inc., to make and sell a new weight loss pill. Vivus’ Qnexa was rejected in July and Orexigen’s Contrave will go before the FDA panel in December to seek approval.
The FDA wants Arena to do a study to find the efficacy of lorcaserin. They recommend that Arena do a trial with over weight people with type 2 diabetes and include lorcaserin versus a placebo or fake drug for one year. Arena says that the trial has been completed and they will be announcing results in the next few weeks and have the study completed by the end of the year.
The FDA requires that lorcaserin has the difference of average weight loss be at least 5 percent between the patients taking the drug and those taking a placebo. Those taking lorcaserin lost an average of 5.8 percent of their weight while those on the placebo only lost 2.5 percent.
There is also concerns of the risk of cancer. In testing, female rats were given a higher dose than humans would use and they developed breast tumors. Arena needs to alleviate the concerns of cancer or it will significantly delay the FDA approval.
Obesity drugs are hard to get approval for because they usually run into safety problems and they only produce a small amount of weight loss.
