Biotech Values

[genisi]

Gene testing could have saved weight-loss drug

http://www.reuters.com/article/idUSN1220142320100812

* Genomics could have kept Acomplia on market - study

* Finding points way to better drug development

By Julie Steenhuysen

CHICAGO, Aug 12 (Reuters) - Genetic testing might have helped identify people who would become depressed or suicidal while taking Sanofi-Aventis' (SASY.PA) weight loss drug Acomplia, which might have helped keep the drug on the market, U.S. researchers said on Thursday.

They said partial results from a study of the drug in which five people committed suicide confirmed that it increased the risk of psychiatric side effects.

The study was halted in 2008 and the company pulled the drug from the market in Europe, but the researchers think genetic testing might have been able to identify people who were at risk of the side effects, and rescue the once-promising treatment, said Dr. Eric Topol of Scripps Translational Science Institute in La Jolla, California, whose study appears in the journal Lancet.

Acomplia, known generically as rimonabant, blocks the same reward receptors in the brain that become active during marijuana use, and for some people, it caused serious bouts of anxiety and depression that led to suicide.

"Finding the gene for severe adverse drug reactions is a lot easier than we ever thought it would be," Topol said in a telephone interview.

Topol thinks if they had thought to collect genetic information on the study's more than 18,000 participants, they might have spared the drug.

"We probably could have figured out genomically who was susceptible and that drug could be quite viable," Topol said in a telephone interview.

Hopes had been high for Acomplia, which not only helped people lose weight but helped them achieve more normal blood sugar levels and improvements in blood fats known as triglycerides and HDL cholesterol, the so-called good cholesterol.

In Topol's study, which looked at the heart benefits of the drug, four patients taking rimonabant and one person taking a placebo committed suicide.

Of the results they had, they found deaths from heart disease, heart attacks and strokes occurred at similar rates in both groups, and they did find that serious psychiatric side effects were increased in rimonabant users compared with placebo.

Due to these side effects, the European Medicines Agency recommended doctors no longer prescribe rimonabant from October 2008. Concerns about side effects prevented the drug from winning U.S. regulatory approval.

Topol says it is likely too late to revive Acomplia, but he said the study does offer insights about how to avoid similar problems with drugs in the future.

"Genomics could potentially be used to pre-empt use of the drug in individuals with risk of serious adverse events," he said in a statement.