Print Alexi Friedman/The Star-Ledger By Alexi Friedman/The Star-Ledger The Star-Ledger
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on May 13, 2013 at 1:29 PM, updated May 13, 2013 at 3:06 PM
Janssen Federal regulators have granted priority review for Janssen Research & Development’s experimental treatment for hepatitis C, a contagious liver disease that affects more than 3 million people in the United States.
Today, Raritan-based Janssen said the Food and Drug Administration gave the designation to its application for simeprevir, an investigational medicine taken as a once-a-day pill in combination with pegylated interferon and ribavirin.
The treatment is for adult patients with genotype 1 chronic hepatitis C, according to Janssen, a unit of New Brunswick-based Johnson & Johnson.
The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. The regulatory federal review process is likely to last no more than six months, with a decision expected by year's end, said Janssen spokesman Craig Stoltz. No pricing information was available.
Gaston Picchio, who is Janssen’s hepatitis disease area leader, called hepatitis C a “global epidemic,” and said in a statement the FDA’s designation is “a significant step forward in making this therapy available to physicians” and their patients.
Simeprevir, developed by Janssen and Swedish drug company Medivir AB, works by blocking the protease enzyme that allows the hepatitis C virus to replicate in host cells.
The submission for simeprevir followed data from clinical trials in which patients who had relapsed after having received interferon-based treatment were administered the Janssen drug.
The most common side effects reported were fatigue, itch and fever.
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About 150 million people worldwide are infected with hepatitis C, and 350,000 people each year die from the disease, according to information on the World Health Organization web site.
The disease can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. The most common ways it can be transmitted is through contaminated blood transfusions and injections with contaminated syringes, the World Health Organization said.
Less common is transmission from sex with an infected person. The disease cannot be spread through breast milk, food or water, or casual contact such as kissing, and sharing food with an infected person, according to the website.