Arena Pharmaceuticals are extremely unlikely to get full approval

Another one bites the dust! The weight loss drug being developed by Arena Pharmaceuticals has been given the thumbs down from an investigational group set up to advise the US Food and Drug Administration. The FDA Endocrinologic and Metabolic Drugs Advisory Committee were split nine votes to five in that the clinical testing data did not prove that the benefits of the drug lorcaserin for use in overweight and obese people outweighed its potential risks.

Another concern which was raised by the FDA committee was that in some of the lorcaserin studies done with rats breast tumours were observed with those dosed at seven times higher than normal dose.  This was not observed however with 7,000 human volunteers who used this weight loss drug.

In the Arena Pharmaceuticals Phase III BLOOM clinical trial those patients on the lorcaserin drug lost an average of 5.8% of their body weight compared to only 2.2% in the placebo group.  The FDA pointed out that it did not meet a "mean efficacy criterion" of 5% between patients on the weight loss drug compared to those patients on the placebo. 

The Arena Pharmaceuticals chief executive, Mr. Jack Lief said that they still believed the lorcaserin had a "positive benefit-risk profile" and that they would be collaborating with the FDA over the course of its review. Unfortunately however for Arena Pharmaceuticals they are extremely unlikely to get full approval following this setback. Its stock has fallen by 45 percent on the financial markets and could fall even further.

Effective medications to treat obesity like Xenical and Reductil are worth a fortune to their respective drug companies and that is why millions of pounds go into research and development for new diet medications every year. No new weight loss medications have been approved in the US or UK for years.