Regulatory

New hepatitis C drug gets positive FDA review

Last Updated: 2013-10-22 17:12:09 -0400 (Reuters Health)

(Reuters) - A new hepatitis C drug made by Johnson & Johnson showed an acceptable safety profile in clinical trials, reviewers for the U.S. Food and Drug Administration said on Tuesday.

The drug, simeprevir, was tested in combination with standard hepatitis C drugs, peginterferon-alpha and ribavirin, in adult patients who had failed previous interferon-based therapy or had not received medication at all.

The major safety signal identified in the review of the drug involved rash and/or photosensitivity and the FDA reviewers said they plan to include a related warning in the drug's label.

The reviewers said that the drug would be categorized as a "Pregnancy Category C" in labeling, which means that the potential benefits of the drug may warrant its use in pregnant women, even though animal trials showed the drug had some adverse effects on a fetus.

The briefing documents were released prior to Thursday's meeting of an advisory panel of independent experts to discuss the drug's safety and efficacy, vote on an approval recommendation, and the need for warnings or further trials.

Hepatitis C kills more than 15,000 Americans each year, mostly from hepatitis C-related illnesses, such as cirrhosis and liver cancer.