FDA clears Johnson & Johnson hepatitis C drug

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WASHINGTON (AP) — Federal regulators on Friday approved anew drug from Johnson & Johnson
for use in treating chronichepatitis C infections.The U.S. Food and Drug Administration saidit approved the
drug, a protease inhibitor that blocks a protein neededby the virus to replicate.The Johnson &
Johnson drug, namedOlysio, is designed to eliminate hepatitis C, the most common form ofthe liver-destroying
virus. It is a daily pill taken in combination withthe long-established drug cocktail used to treat the most
common formof the virus.The FDA’s decision comes less than a month after an FDA advisory panel voted
unanimously in favor of approving the treatment.Olysio is the third FDA-approved protease inhibitor for
treatment of hepatitis C, the FDA said.More than 3 million people in the U.S. have hepatitis C, a
blood-borne disease that is blamed for 15,000 deaths a year.Johnson& Johnson is one of a half-dozen
companies working to develop moreeffective treatments for the virus as it threatens to become a majorhealth
epidemic among baby boomers and middle-age Americans.Peopleborn between 1945 and 1965 are five times more
likely to have the virusthan people of other age groups. Many of them contracted the virus bysharing needles
or having sex with an infected person in their youth.The disease was also spread by blood transfusions
before 1992, whenblood banks began testing for the virus.For the last 20 years,the standard treatment for
hepatitis C has involved a grueling one-yearregimen of pills and injections. These two antiviral drugs,
known asribavirin and interferon-alpha, cause flu-like side effects includingnausea, diarrhea and muscle
achiness. The introduction of new drugs fromMerck and Vertex Pharmaceuticals in 2011 helped shorten the
treatmentperiod and boost cure rates as high as 75 percent.Olysio appearsto be slightly more effective than
the standard of care, curing 80percent of patients who had not previously been treated for the
disease,according to studies submitted to the FDA.More significantly,the drug helped most patients cut the
amount of time they had to takethe traditional drug cocktail, with its unpleasant side effects, to sixmonths
rather than one year.Additionally, members of the FDA’sadvisory panel said the drug’s once-a-day dosage
should be far moremanageable for patients than the current drugs from Merck and Vertex,which require taking
12 pills or six pills a day, respectively.Copyright 2013 The Associated Press. All rightsreserved. This
material may not be published, broadcast, rewritten orredistributed.

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