Carter's Little Liver Pills

Breakthrough Liver Medicine Advances

What appears to be a breakthrough liver medicine moved another step closer to submission for FDA approval with the announcement of favorable results in a pivotal phase III study yesterday. The study showed that obeticholic acid was effective in treating primary biliary cirrhosis in a double-blind, placebo-controlled trial.

The drug was previously found to be so effective in non-alcoholic fatty liver disease — a serious complication of obesity — that a phase II study was abruptly discontinued in January because it would have been unethical to continue treating the control patients with a placebo.

Along with the good news of efficacy came some data on adverse cardiovascular events that worried investors and took a little over 10% off of the stock price today for Intercept, the biotech company developing the drug. Even so, their stock has gained 487% in value this year. Analysts are forecasting sales of $4 to $9 billion for the drug.

The medical need for this drug is great. Sadly, part of that need stems from the consequences of untreated obesity. We have too few tools for treating obesity, too little utilization of the tools we do have, and too few incentives for developing new ones.

So you can be sure, many more expensive new treatments for the problems of untreated obesity will be coming our way. Maybe someday, we’ll get to the root of the problem.

Click here to read more from the Pharma Letter and here for prior news of the trial in fatty liver disease.

Carter’s Little Liver Pills, photograph © Lew (tomswift) Holzman / flickr

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