FDA Nixes Weight Loss Drug Lorcaserin On Safety Ground

October 26th, 2010 - 5:54 pm ICT by GD  

By Ranjan Bhaduri
getty_n_101410_pileofpillsSan Diego, Oct 26, (THAINDIAN NEWS) In a recent move the Food and Drug Administration in the USA turned down the application for a new medicine meant for weight loss manufactured by Arena Pharmaceuticals, Inc. The name of the drug is Lorcaserin. The FDA shot a mail to the company saying that the drug is being rejected owing to a number of safety concerns both non clinical and clinical. The entity also said that the drug should be placed in the Controlled Substance Act section 4. The companies manufacturing the drug said on their part that ” Obesity is an epidemic in America, and our goal is to bring locaserin to physicians and patients who need additional weight-loss options”.

Arena Pharmaceuticals, Inc is going to meet the officials of FDA to make its points clear to them. The company has spent a billion dollars and almost 12 years in developing the drug. Therefore it does not want to let it go so easily and expects to change the stance taken by FDA on it. Jack Leif the CEO of the company said in his statement We will work with the agency to address the issues with our new drug application as quickly as possible.”

The FDA on its part said that it is rejecting the drug because it is not much effective and more importantly the drug when taken in high doses can lead to cancer. The company will now have to prove that the studies conducted on rats do not necessarily co relate to human cases. The company is based in San Diego and has made the drug in collaboration with Eisai Pharmaceuticals.

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