Home » Obesity drug Lorcaserin may be approved by FDA despite some hiccups

Obesity drug Lorcaserin may be approved by FDA despite some hiccups

The desire to look attractive and slender is universal and this is the reason some drug companies make millions of dollars in revenue from selling obesity solution products. Not all such weight loss products bring equal results though. Some of them can also lead to development of several side effects. Generally, weight loss drugs that come with approval by FDA are considered safe by the users. Pharmaceutical companies try to get their drugs FDA approved for this reason.

In a recent development, government health regulators received recommendation from advisers on approving Lorcaserin. If it gets FDA nod, that will be a first for a prescription weight loss medication in the USA after a long gap. However, the only aspect that could prove to be a roadblock for getting approval for the product is its side effects related to cardiac health. After this, the stock prices of Arena Pharmaceuticals shot up. Arena’s lorcaserin, meant for weight loss got a thumb up from expert advisers who elected it with an 18-4 vote. They said that the drug has some side effects but its benefits for fighting obesity outweigh the potential drawbacks by large.

Jack Lief, the CEO of Arena said in his statement that his company will cooperate with the FDA by all possible means. FDA will let the company know of its decision by the end of June this year, as per the latest updates. The drug is meant for people suffering from obesity and weight-related health issues like high blood pressure levels. While the FDA is under no compulsion to adhere to the recommendations made by its advisory panel, in general it does so. Arena approached FDA last year for approving this drug but that time its plea was rejected. The reason cited by FDA for rejection was potential adverse effects of the product.

The vote of the panel was preceded by a favorable review of lorcaserin by federal health regulators. During the previous trial of the medication, FDA scientists objected to approving the drug as they had found its negative effects on animals that included development of tumors. This time the company has submitted additional data for winning the favor of FDA and getting the drug approved. The new studies suggest that the drug can cause development of tumor only in a handful of cases. However, its detractors are still worried about its capability to cause damage to cardiac valves and make blood pressure shot up, in diabetes patients.

Earlier in 2012, Vivus Inc, arch rival of Arena won approval from the FDA for selling its diet product Qnexa. However, in a later note Vivus said that FDA pushed back the date for final decision on Qnexa to mid of July. It is true that obese people always look for drugs and supplements that will help them to shed weight but these drugs are no magic cure for obesity.

As per the data available from research, Lorcaserin usage results in moderate weight loss in adult individuals. Over 38 percent of test candidates lost 5 percent of their body weight and this in fact is adequate for getting nod from FDA. However, average weight loss result with Qnexa is far better, as studies have shown.

However, Arena is leaving no stone unturned to market the product well and the recommendation from FDA advisory body has only encouraged the company. It said that to market Lorcaserin well it has tied up with Eisai Inc a Japan based company and this will help it in capturing markets outside the USA. Eisai will take up distribution and marketing task once the drug gets final approval from FDA.

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