Provided by ABC News
WASHINGTON October 22, 2013 (AP)
By MATTHEW PERRONE AP Health Writer
An experimental hepatitis C drug from Johnson & Johnson appears to be slightly more effective at eliminating the virus than currently available treatments, though federal safety reviewers say it also causes rash and sunburn in some patients.
The Food and Drug Administration posted its review of simeprevir online ahead of a public meeting Thursday where experts will vote on whether to recommend the drug's approval.
More than 3 million people in the United States have hepatitis C, a blood-borne disease linked to 15,000 deaths a year. The disease slowly eats away at the liver over 20 to 30 years and most people don't even realize they have the virus until after liver damage occurs.
Drugmakers see hepatitis treatments as potentially lucrative because the disease is expected to grow into a major public health problem as the U.S. baby boom generation ages.
For most of the last 20 years, the standard treatment for hepatitis C involved a grueling one-year regimen of pills and injections that caused flu-like symptoms and cured less than half of patients. Then in 2011, the FDA approved two new drugs from Merck and Vertex Pharmaceuticals that raised the cure rate to about 65 and 75 percent, respectively, when combined with the older treatments.
J&J's new drug appears to raise the level of effectiveness again: simeprevir cured 80 percent of patients who had not previously been treated for the disease, according to the FDA. The New Brunswick, N.J., company is seeking approval to combine the drug with the standard treatment regimen for patients with the most common form of the virus.
But the agency's review is not all positive. FDA scientists note that 25 percent of patients taking the drug developed a rash during the first 12 weeks of treatment. About 5 percent of patients also developed sunburn as a side effect of the drug.
On Thursday the FDA will ask a panel of outside experts whether the drug should carry warnings about rashes and sunburn on its label. The agency also wants to know whether "sun-protection measures should be recommended for all patients."
The FDA is not required to follow the advice of its panelists, though it often does.
The same panel of experts will review another proposed hepatitis C drug from Gilead Sciences Inc. on Friday. Some analysts expect that drug, known as sofosbuvir, to become the leading drug for the disease, based on research showing it cured 90 percent of patients in 12 weeks.
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