Belviq, the first new medications for weight loss that was released on the U.S. market for more than ten years, was approved by the U.S. Food and Drug Administration. In May this year, the FDA’s experts panel voted 18-4 to recommend the Belviq approval, saying that drug outweighed the risks when it came to a long-term use.
In May a panel of expert advisers to the FDA voted 18-4 to recommend approval of Arena’s drug, concluding that its benefits “outweigh the potential risks when used for a long term period” in overweight and obese people.
This drug application was reviewed by the FDA in 2010 and was denied because for safety reasons. In 2010 a lot of experts were noticed tumors that occurred during trials on animals. This year the drug application was resubmitted with as additional data and there was a little risk of tumors, according to the FDA.
This medication from Arena Pharmaceuticals demonstrated modest weight loss and high safety during clinical trials and so was endorsed by the FDA. The FDA also noted that the medication was designed for adults with overweight and those who are obese. The feature of Belviq is that people with high cholesterol or diabetes may take it as well. Experts say that Belviq approval is an important step in new treatments of obesity, which underlying its causes, regardless of the drug moderate effect. The drug is expected to be released on the market in early 2013.
Other drugs reviewed by the FDA
There were several medications reviewed and not approved by the FDA in 2010-2011 and Belviq was one of them. Another medication was Qnexa and it was the most promising among those drugs, with the best effectiveness in weight-loss, but all the medications were disapproved because of some really serious side effects. Qnexa will be reviewed as well in July this year.
Read more about 2010 weight loss medications reviewed by FDA.
A lot of doctors were asking the FDA to approve new medications for weight loss for a long time because the U.S. obesity was nearly 35%. There were many offerings, but those medications were associated with serious safety issues. One of the good examples is fenfluramine and phentermine combination also called “fen-phen” for short. This combination was not approved by the FDA because it could cause heart valve damage.
With U.S. obesity rates nearing 35% of the adult population, many doctors have called on the FDA to approve new weight-loss treatments. But a long line of prescription weight loss offerings has been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight-loss combination prescribed by doctors, though it was never approved by the FDA. Belviq doesn’t have those chemical pathways, as fen-phen had, so it should not lead to heart issues, according to the FDA. Experts state that the main challenge of the development of weight-loss medications is switching off body’s fundamental directives safely. One of them is to maintain its current weight by taking enough food. The FDA said that Belviq works differently from fen-phen and boost the feeling of fullness, thus reducing appetite.
The studies of Arena company showed average patients lost was 3%-3.7% of their body weight over one year, which is considered to be a modest weight loss. FDA effectiveness standard is 5% of weight loss and 47% of all patients (without diabetes) showed at least 5% weight loss. The FDA warns patients to stop taking the drug if they are not able to achieve 5% of weight loss after three months of treatment, because the further treatment may not be that effective and patients are unlikely to see better results. Belviq has some side effects as well. Some of them are a migraine, depression, and memory lapses.
Weight-loss drugs safety issues
During several years, there was an increase in an amount of safety failures for weight-loss drugs. For example, Acomplia, the medication that was discontinued because of psychiatric adverse effects, like suicidal thought and depression. The medication from Abbott Laboratories, called Meridia, showed increased heart attack and strokes rates and so was discontinued as well. The only one medication, approved by the FDA, for long-term treatment was available on the market. This medication was developed by Roche and its name is Xenical. Xenical is not often prescribed because of its side-effect on the digestive system and modest weight-loss.
Experts say the challenge of weight loss drug development lies in safely turning off one of the body’s fundamental directives: to eat enough food to maintain its current weight.
Patrick O’Neil, Obesity Society President, said that he was encouraged by the approval because it underscores the idea of medications needed for the weigh-loss, not only lifestyle changes. He added that the approval was good news because it told them that the FDA thought about obesity issue seriously. However, he pointed out the approval wasn’t the answer to the problem, not even a big part of it.
Another expert, weight loss program at Weill-Cornell Medical College director, Dr. Louis Aronne, explained, that some medications do not work for some people while work extremely well for others and in this case it would be a real field if they would have about ten of medications for weight-loss.