Genetically Engineered Protein OKd for Hepatitis C Treatment
WASHINGTON — The Food and Drug Administration Monday approved a genetically engineered copy of a natural protein for treatment of a common, potentially deadly form of hepatitis.
The FDA notified Schering-Plough Corp. of Kenilworth, N. J., that it may market its version of alpha interferon for use against chronic non-A, non-B hepatitis, also known as hepatitis C.
Hepatitis C, the most common of the three major forms of the disease, is the type of the liver infection most often contracted through blood transfusions. About 170,000 Americans become infected with the hepatitis C virus each year.
About half of those who become infected recover relatively quickly, but the others become chronically infected. A chronic infection may lead to cirrhosis, liver cancer, liver failure and even death.
Alpha interferon is found at very low levels in the human body to help fight viruses.
The substance has been reproduced for medical use in large amounts by so-called gene-splicing techniques. A gene that carries the coding for production of alpha interferon is inserted into harmless bacteria, causing the bacteria to produce large amounts of the protein.
The genetically engineered copy, Intron-A, previously was approved for treatment of hairy cell leukemia, Kaposi’s sarcoma and genital warts.
It is already being sold in other countries for hepatitis C.
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