The Food and Drug Administration on Monday gave the go-ahead to Schering-Plough Corp.'s recombinant alfa interferon asthe first approved treatment of chronic hepatitis B.
The decision follows an FDA advisory board's recommendationlast November to approve interferon alfa-2b injections fortreating hepatitis B. Schering's Intron A was approved fortreating hepatitis C (also called non-A, non-B hepatitis) inFebruary 1991.
"Hepatitis B is a serious public health problem that is too oftenoverlooked," said Health and Human Service Secretary LouisSullivan. "This treatment will help save lives and reduce thesuffering that accompanies this disease."
About 750,000 to 1 million Americans are hepatitis B viruscarriers, and one in four will eventually develop chronic activehepatitis, which can lead to cirrhosis, liver cancer and death,according to the federal Centers for Disease Control in Atlanta.
An estimated 300,000 Americans are infected with the viruseach year. "It is fortunate that there is now a treatment thatmay halt the progression of the disease," said David A. Kessler,FDA commissioner.
In two controlled clinical studies, patients with chronichepatitis B showed improvement after being treated withIntron A. Patients were given a four-month regimen at a dailyrate of 5 million to 10 million international units. Clinicalimprovement was determined by detecting a reduction in thepatient's blood of hepatitis B markers and of the level of liverenzyme (alanine aminotransferase), which is associated withliver damage.
Schering's Intron A is also approved for use in the UnitedStates for treating hairy cell leukemia, AIDS-related Kaposi'ssarcoma and genital warts.
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