SILVER SPRING, Md. (AP) — An experimental hepatitis C drug from Johnson & Johnson has won unanimous support from government advisers, who say the medication should be approved to treat patients infected with the liver-destroying virus.
All 19 members of the Food and Drug Administration's panel of virus experts voted in favor of approving J&J's simeprevir, a daily pill designed to eliminate the most common form of hepatitis C.
The FDA is not required to follow the group's recommendations, although it often does. A decision on the drug is expected next month.
Roughly 3.2 million people in the United States have hepatitis C, a blood-borne disease that causes liver damage and is blamed for 15,000 deaths a year.
J&J is one of a half-dozen companies working to develop more effective treatments for the virus as it threatens to become a major health epidemic among baby boomers and middle-age Americans.
J&J is seeking approval to combine its pill with the long-established drug cocktail used to treat the most common form of the virus.
The panel's endorsement on Thursday came with a number of conditions.
The panelists stressed that the drug is less effective in patients with a common genetic mutation called Q80K and that people with the abnormality should be screened out so they can receive other drugs.
The group also said the drug's label should warn patients and doctors that sunburn is a common side effect.
Finally, panelists said that the FDA should require J&J to conduct additional studies of the drug's effectiveness in members of minority groups, especially African-Americans who are disproportionately infected.
The FDA meeting comes as federal health officials urge all baby boomers to get tested for the virus, which can go unnoticed for decades before causing symptoms. People born between 1945 and 1965 are five times more likely to have the virus than people of other age groups. Many of them have contracted the virus by sharing needles or having sex with an infected person in their youth.
For the past 20 years, the standard treatment for hepatitis C has been a grueling one-year regimen of pills and injections.
Today, the same panel will review another experimental hepatitis C drug, this one from Gilead Sciences Inc. Many analysts expect the drug, known as sofosbuvir, to become the leading treatment for the disease, based on research showing that it cures 90 percent of patients with the most common form of hepatitis C in 12 weeks.