Last month the FDA’s Endicrinologic and Metabolic Drug Advisory Committee approved Arena Pharmaceutical’s new weight loss drug Belviq(lorcaserin) in an 18-4 vote.
Lorcaserin, which will be marketed under the trade marked name Belviq, is a weight loss medication developed to battle obesity. It acts as an appetite suppressant which is essentially effective by causing patients to feel less hunger sensations. Ultimately the body ingests less food and thus less calories, resulting in weight reduction. The drug has been approved for patients with a Body Mass Index (BMI) over 30 or for those with a BMI of at least 27 suffering from additional conditions such as high blood pressure and diabetes.
Belviq/Lorcaserin is the first drug of its kind to gain approval in 13 years, potentially paving the way for a handful of others, which may or may not be targeted at certain factions of the obese population. Considering the obesity rate of the U.S. alone, a prescription weight loss supplement such as this could potentially become a sensation. Arena Pharmaceuticals, the manufacturer of Belviq/Lorcaserin, and its investors are expecting significant profits, especially upon approval with the European Union.
Wednesday, July 18, 2012
Lorcaserin: The new diet drug: A blessing or a curse?
Potential problems with Belviq/Lorcaserin….
Belviq/Lorcaserin has picked up some scars along the road to approval. Although side effects reported in association with its use appear tobe mild and for the most tolerable, it had been previously rejected by the FDAon the grounds that its safety profile had not been sufficiently explored. This rejection was in 2009.
It works similar to the now banned drug, Fenfluramine, which was the culprit in a massive amount of heart related injuries such as cardiacfibrosis and cardiac valvulopathy and marketed under the name Fen-Phen. Arena claims the drug is much more selective than Fenfluramine, so the risks are significantly decreased.
In animal studies, reports show that there were occasions of tumors that grew in the mammary tissue of rats. This also remains a concern, a concern that has prompted the FDA to issue a warning to the maker despite approving the drug in an 18-4 vote. Substantial long-term studies are not available and with the approval of Belviq/Lorcaserin, other drugs, with scars of their own, one particularly pertaining to complications with heart valves are vying for a spot in the market. The obesity drug market is still rather unexplored which leaves additional speculation to come.
Belviq/Lorcaserin has picked up some scars along the road to approval. Although side effects reported in association with its use appear tobe mild and for the most tolerable, it had been previously rejected by the FDAon the grounds that its safety profile had not been sufficiently explored. This rejection was in 2009.
It works similar to the now banned drug, Fenfluramine, which was the culprit in a massive amount of heart related injuries such as cardiacfibrosis and cardiac valvulopathy and marketed under the name Fen-Phen. Arena claims the drug is much more selective than Fenfluramine, so the risks are significantly decreased.
In animal studies, reports show that there were occasions of tumors that grew in the mammary tissue of rats. This also remains a concern, a concern that has prompted the FDA to issue a warning to the maker despite approving the drug in an 18-4 vote. Substantial long-term studies are not available and with the approval of Belviq/Lorcaserin, other drugs, with scars of their own, one particularly pertaining to complications with heart valves are vying for a spot in the market. The obesity drug market is still rather unexplored which leaves additional speculation to come.
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