Johnson & Johnson (JNJ)’s and Medivir AB (MVIRB)’s experimental hepatitis C treatment is safe and effective, U.S. regulators said, providing a boost to the companies as they try to reach a highly competitive market for new treatments.
The drug known as simeprevir helps cure patients of the infectious disease that can lead to a liver transplant, Food and Drug Administration staff said in a review today ahead of an Oct. 24 meeting of agency advisers to discuss the medicine. The FDA is scheduled to decide whether to approve simeprevir for sale by Nov. 27.
The FDA report recommended potential users of the drug should be screened for a mutation called Q80K polymorphism that is linked to resistance.
J&J, based in New Brunswick, New Jersey, and Medivir, based in Huddinge, Sweden, are seeking approval for their once daily pill to treat chronic hepatitis C patients with the genotype 1 infection, the most common form of the condition, who have liver disease and haven’t been treated before or who have failed interferons.
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