J&J-Medivir’s Drug Works Against Hepatitis C, FDA Staff Says

Johnson & Johnson’s and Medivir AB’s experimental hepatitis C treatment is safe, U.S. regulators said in a report suggesting that it may be less effective in some potential users.

Hepatitis C patients should be screened for a genetic mutation called Q80K polymorphism that causes the simeprevir drug not to work as well, Food and Drug Administration workers also said in the review today ahead of an Oct. 24 meeting of agency advisers to discuss the medicine. People with the mutation should seek other therapies, the report said. J&J agreed with the recommendation in the New Brunswick, New Jersey-based company’s meeting document also released today.