Simeprevir, a drug designed to chronic hepatitis C in adults with compensated liver disease has been granted priority review by the U.S. Food and Drug Administration. The treatment is currently being tested as a combination drug with existing hepatitis C medications, such as pegylated interferon and ribaverin. The allowance for a faster review signifies that the FDA believes that the drug has the potential to be a major advance in the treatment of patients with genotype 1 chronic hepatitis C. A decision regarding the sale of simeprevir is expected to be made by November 2013, after the results of the study are released.
The drug, which is being developed by Janssen Research & Development Ireland and Medivir AB, works to treat both liver fibrosis and hepatitis by blocking the enzyme that allows the virus to survive. It is currently being tested on untreated adult patients who have relapsed from prior treatment. The drug is administered in daily doses of 150-milligram capsules. It has also been submitted for approval in Europe and Japan.
"This is a very important step [in] bringing simeprevir closer to the market, making this therapy available to hepatitis C patients," said Charlotte Edenius, executive vice president of development at Medivir.
Hepatitis C, which is transmitted by blood, is one of the primary causes of liver disease and currently infects roughly 150 million people across the globe. Approximately 350,000 people die of the disease annually, according to the World Health Organization. Individuals may prevent hepatitis C by not sharing needles with others, as well as using condoms during sex or practicing abstinence. Therapy options are limited, but left untreated, the disease can evolve into cirrhosis or liver failure.