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 realise they have the virus until after liver damage occurs.
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 per cent, respectively, when combined with the older treatments.
J&J's new drug appears to raise the level of effectiveness again, simeprevir cured 80 per cent of patients who had not previously been treated for the disease, according to the FDA.
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But the agency's review is not all positive. FDA scientists note that 25 per cent of patients taking the drug developed a rash during the first 12 weeks of treatment. About 5 per cent 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 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 per cent of patients in 12 weeks.