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J&J's new hepatitis C drug gets positive FDA review
October 22, 2013 / 3:45 PM / in 4 years

J&J's new hepatitis C drug gets positive FDA review

Oct 22 (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.

J&J shares were up nearly 1 percent to $92 in morning trade on the New York Stock Exchange.

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, an infection of the liver transmitted through the blood, kills more than 15,000 Americans each year, mostly from hepatitis C-related illnesses, such as cirrhosis and liver cancer.

Investors are currently focused on new hepatitis C treatments that can exclude the use of the difficult-to-tolerate injected drug interferon.

Sales of hepatitis C drugs that are needed to be taken with interferon, like simeprevir, have been declining as patients wait for the all oral treatment regimens that promise high efficacy without the side effects of interferon.

Gilead Sciences Inc, Vertex Pharmaceuticals Inc , AbbVie and Bristol-Myers Squibb are all trying to come up with the first all-oral hepatitis C treatments.

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