J&J Drug Simeprevir Receives Positive Feedback from FDA

Johnson & Johnson's new hepatitis C drug has just received positive feedback from the U.S. Food and Drug Administration (FDA).

Reviewers of the FDA tested the drug, simpeprevir, in combination with standard hepatitis C drugs, peginterferon-alpha and ribavirin, in adult patients who had previously failed when working with interferon-based therapy, according to Reuters. 

Various reports note that a side-effect of the product includes rash and/or photo-sensitivity, which the FDA reviewers said they plan to include via a related warning for the drug's label.

The drug has currently been labeled in "Pregnancy Category C" as there could be potential benefits of it for pregnant women even though animal trials show that the drug had some adverse effects on a fetus.

Hepatitis C is a serious liver disease caused by the hepatitis C virus, which is spread through direct contact with the blood of infected people and ultimately affects the liver. Chronic hepatitis C can lead to serious and life-threatening liver problems, including liver damage, cirrhosis, liver failure or liver cancer. Though many people with hepatitis C may not experience symptoms, others may have symptoms such as fatigue, fever, jaundice and abdominal pain. 

Pregnant women can pass on hepatitis C to their child when giving birth. Statistics show that there is approximately a 1 in 20 chance that it could be passed on to a baby. It is also not recommended that women breast feed their babies if they test positive for hepatitis C.