SILVER SPRING, Md. - 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, though it often does. A decision on the drug is expected next month.
Roughly 3.2 million people in the U.S. 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.
"We clearly need better drugs and the evidence is strong that this is a better drug," said panelist Dr. Curt Hagedorn of the Central Arkansas Veterans Healthcare Service.
New Brunswick, N.J.-based 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.
Despite the unanimous vote Thursday, the panel's endorsement 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.