Madrigal Pharmaceuticals said Monday that its experimental treatment for fatty liver disease improved liver biopsies by two different measures in a study of 950 patients, reducing the fat deposits and fibrotic scarring that are hallmarks of the disorder, known medically as NASH.
The results, issued in a press release, could pave the way for the medicine, resmetirom, to reach the U.S. market soon without waiting for the completion of a larger trial. The Food and Drug Administration has said that these liver biopsy measures would be “reasonably likely” to predict that a NASH drug will prove effective in larger trials, the agency’s standard for accelerated approval.
NASH, short for non-alcoholic steatohepatitis, is both a serious disease and an increasingly common one. Even a 5% share of the potential market, assuming a price of $15,000 a year, would represent $8.5 billion in annual sales, according to a presentation sent to investors by Liisa Bayko, an analyst at Evercore ISI, an investment bank.
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