First Drug for Chronic Hepatitis B Approved : Medicine: The biotech medication is already used to treat other diseases. Sales are expected to jump $10 million in 6 months.
The U.S. Food and Drug Administration on Monday announced approval of the first chronic hepatitis B treatment, a biotech drug called interferon alfa-2b that is already in use for hairy cell leukemia and Kaposi’s sarcoma, an AIDS-related disease.
Schering-Plough, the manufacturer of the drug, said it expects the new application will boost sales of the drug by $10 million in the next six months and that in five years sales of the drug could reach $55 million a year.
The announcement should also benefit Biogen Inc., a Cambridge, Mass.-based biotech firm that developed the basic interferon technology and licenses it to Schering-Plough. Interferon is a copy of a naturally occurring protein manufactured through biotechnology techniques.
Interferon was one of the first biotechnologies focused on by many start-up companies, according to Cynthia Robbins-Roth, editor of Bioventure View, an industry newsletter. While it proved something of a disappointment in cancer therapy, antiviral uses such as this newest hepatitis application show that interferon may be making a comeback, she said.
About 750,000 Americans are now hepatitis B carriers, and one in four of those will develop chronic active hepatitis, according to the Centers for Disease Control. The disease is an inflammation of the liver linked to the development of cirrhosis, liver failure and cancer.
“Hepatitis B is a serious public health problem that is too often overlooked,” said Health and Human Services Secretary Louis W. Sullivan in a written statement. “This treatment will help save lives and reduce the suffering that accompanies this disease.”
Dr. Karen Lindsay, an associate professor at USC Medical School who helped design the drug’s clinical trials, said hepatitis B is a major problem in the Los Angeles area. Millions of people in Asia suffer from the disease, and some immigrants bring the disease with them. Those at high risk for hepatitis B also include intravenous drug abusers, people with many sex partners and health care workers.
Hepatitis B is transmitted through sexual contact, from mother to infant and through exposure to infected blood and blood products. However, blood-screening techniques have greatly reduced the risk of exposure through transfusions, Lindsay said.
In clinical trials, about 40% of patients treated with interferon alfa-2b showed improvement, and none of those relapsed during a follow-up period from two to six months after treatment ended.
While the drug is the only treatment available for hepatitis B, it is not without side effects. Most patients in the trials experienced some mild to moderate adverse reactions, and 21% to 44% experienced more serious flu-like symptoms.
